FDA.reportPublic FDA data

BioHorizons

Primary DI
00847236016487
Brand
BioHorizons
Company
BIOHORIZONS IMPLANT SYSTEMS, INC
Model
TA-GY-PN
Device description
Grey Temporary Cylinder, PEEK, Non-hexed
Published
2021-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093321000
K223697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093321000BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEMBioHorizons Implant Systems, Inc.2010-04-02DZE
K223697000MRI compatibility for existing BioHorizons dental implants and abutmentsBioHorizons Implant Systems, Inc.2023-10-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847236016487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847236016487008472360164878472360164870847236016487

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
967279910
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847236025762BioHorizonsCNODS12026-04-06
00847236025779BioHorizonsCNODS22026-04-06
00847236025786BioHorizonsCNODS32026-04-06
00847236025793BioHorizonsCNODS42026-04-06
00847236025809BioHorizonsCRODS12026-04-06
00847236025816BioHorizonsCRODS22026-04-06
00847236025823BioHorizonsCRODS32026-04-06
00847236025830BioHorizonsCRODS42026-04-06
00847236027971BioHorizonsCNIDH112026-04-01
00847236027988BioHorizonsCNIDH182026-04-01
00847236027995BioHorizonsCNIDR112026-04-01
00847236028008BioHorizonsCNIDR182026-04-01
00847236028015BioHorizonsCRIDH112026-04-01
00847236028022BioHorizonsCRIDH182026-04-01
00847236028039BioHorizonsCRIDR112026-04-01
00847236028046BioHorizonsCRIDR182026-04-01
00847236028053BioHorizonsPROID302026-04-01
00847236028060BioHorizonsPROID3342026-04-01
00847236028077BioHorizonsPROID382026-04-01
00847236028084BioHorizonsPROID422026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710329Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710428prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710442prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710459prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710480Concave Hex. Healing Cap 6.mmCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710510prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710527prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710862prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710879prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710886prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710985prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711005prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711210Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711487Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711500Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711524Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711678Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712163prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712255prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712262prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
06009544052036N/ASOUTHERN IMPLANTS (PTY) LTDNHA2026-09-30
00840481138492LOCATOR, compatible with Nobel BiocareZest Anchors, LLCNHA2026-09-29
07290112780041Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780058Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780065MAGIX Dental Implant Ø4.2 L10mm PrimeCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780072Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780089Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780096Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780102Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780119Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29