FDA.reportPublic FDA data

Brånemark System®

Primary DI
07332747001075
Brand
Brånemark System®
Company
Nobel Biocare AB
Model
32135
Catalog number
32135
Device description
Brånemark System® Mk III Groovy WP 5.0x11.5mm
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945398000BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURENobelpharma USA, Inc.1995-04-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747001075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747001075073327470010757332747001075

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags#

DUNS number
353939929
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747086904NA37677376772022-07-25
07332747225433NobelProcera®NBRA_FDATEST_2NBRA_FDATEST_22025-05-08
07332747214918Nobel Biocare®3019313019312026-04-09
07332747214925Nobel Biocare®3019323019322026-04-09
07332747214932Nobel Biocare®3019333019332026-04-09
07332747214949Nobel Biocare®3019343019342026-04-09
07332747221510Nobel Biocare®3022543022542026-04-09
07332747221527Nobel Biocare®3022553022552026-04-09
07332747221534Nobel Biocare®3022563022562026-04-09
07332747223385Nobel Biocare®3022653022652026-04-09
07332747223392Nobel Biocare®3022643022642026-04-09
07332747223408Nobel Biocare®3022663022662026-04-09
07332747224436Nobel Biocare®3024853024852026-04-09
07332747224443Nobel Biocare®3024863024862026-04-09
07332747224450Nobel Biocare®3024883024882026-04-09
07332747224467Nobel Biocare®3024873024872026-04-09
07332747224474Nobel Biocare®3024893024892026-04-09
07332747224481Nobel Biocare®3024903024902026-04-09
07332747236620DTX Studio™ Clinic4.83008512026-03-27
07332747236637DTX Studio™ Clinic4.83008512026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112921663(INOSS System) INOSS FixtureInosys, Inc.DZE2026-08-19
04099797000337CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000344CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000351CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000368CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000375CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000382CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000399CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000405CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000412CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000429CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000436CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000443CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000450CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000467CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000474CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000481CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000498CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000504CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000511CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000528CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000535CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000542CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000559CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000566CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000573CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000580CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000597CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000603CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17
04099797000610CONELOG® SCREW-LINE ImplantALTATEC GmbHDZE2026-08-17