Nobel Biocare Usa Llc: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.; A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..

Agency Publication Date: April 13, 2015

Affected Products

Product: Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immed

Batch No. 13011366, 13011446, 13011544.

Product: Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immed

Batch No. 13010895.

Product: Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immed

Batch No. 13012695.

Product: Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immed

Batch No. 13012523, 13012525, 13012987.

Product: Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immed

Batch No. 13011341, 13013046.

Product: NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immed

Batch No. 13011622, 13013239.

Product: NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed imme

Batch No. 13012851.

Product: NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immedi

Batch No. 13010360.

Product: NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immedia

Batch No. 113010001.

Product: Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed imm

Batch No. 13011317.

Product: Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.

Batch No. 13011452, 13011453.

Product: NobelReplace CC NP 3.5x10mm, Article No. 36700.

Batch No. 13010971, 13010972, 13010976, 13011142, 13011771, 13011772, 13011828, 13011830, 13012480, 13012481, 13012482, 13012640.

Product: NobelReplace CC NP 3.5x11.5mm, Article No. 36701.

Batch No. 13010794, 13010795, 13010977, 13011241, 13011242, 13011370,13011556, 13011836, 13012139, 13012755, 13012840.

Product: NobelReplace CC NP 3.5x13mm, Article No. 36702.

Batch No. 13011774, 13011775, 13011776, 13011826, 13011896, 13012487.

Product: NobelReplace CC RP 4.3x8mm, Article No. 36704.

Batch No. 13011378, 13011379, 13011664.

Product: NobelReplace CC RP 4.3x10mm, Article No. 36705.

Batch No. 13011154, 13011155, 13011202, 13011380, 13011619, 13011621, 13012148, 13012150, 13012520.

Product: NobelReplace CC RP 4.3x11.5mm, Article No. 36707.

Batch No. 13011157, 13011158, 13011204, 13011459, 13011461.

Product: NobelReplace CC RP 4.3x13mm, Article No. 36708.

Batch No. 13011199, 13011200, 13012501, 13012514.

Product: NobelReplace CC RP 5.0x8mm, Article No. 36710.

Batch No. 13013146.

Product: NobelReplace CC RP 5.0x10mm, Article No. 36711.

Batch No. 13011136, 13011367, 13011450, 13012929.

Product: NobelReplace CC RP 5.0x13mm, Article No. 36713.

Batch No. 13010964, 13011549.

Product: NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.

Batch No. 13011140.

Product: NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.

Batch No. 13010297

Product: NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.

Batch No. 13011562

Product: NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.

Batch No. 13011148

Product: NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.

Batch No. 13010961, 13013308

Product: NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.

Batch No. 13010296

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70821

Status: Resolved

Manufacturer: Nobel Biocare Usa Llc

Manufactured In: United States

Units Affected: 27 products (131 units; 17 units; 24 units; 357 units; 73 units; 138 units; 74 units; 7 units; 72 units; 23 units; 32 units; 1456 units; 1155 units; 594 units; 102 units; 1077 units; 679 units; 448 units; 56 units; 636 units; 106 units; 216 units; 23 units; 2 units; 5 units; 53 units; 38 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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