FDA.reportPublic FDA data

Drill stopper ø4.5mm L 6

Primary DI
10810190012366
Brand
Drill stopper ø4.5mm L 6
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
B
Catalog number
TD2-0039
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K143326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143326000T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.2015-05-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810190012366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081019001236610810190012366

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810128461426Back Drill 4.5 X 7.0mmS25-3070-T145070su2026-07-22
10810128461440Back Drill 4.5 X 8.0mmS25-3080-T145080su2026-07-22
10810128461457Back Drill 4.5 X 8.5mmS25-3085-T145085su2026-07-22
10810128461464Back Drill 4.5 X 9.0mmS25-3090-T145090su2026-07-22
10810128461471Back Drill 4.5 x 9.5mmS25-3095-T145095su2026-07-22
10810128461488Back Drill 4.5 X 10.0mmS25-3100-T145100su2026-07-22
10810128463338Back Drill 6.0 X 11.0mmS25-3110-T160110su2026-07-22
10810128464137WireS25-3004-T146000su2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmAR-6593-57Q159o570ar2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmAR-6593-59Q159o590ar2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmAR-6593-77Q159o770ar2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmAR-6593-97Q159o970ar2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmAR-6593-99Q159o990ar2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmAR-6593DT159o90ar2026-07-21
10810128462782StayPort™ Cannula 5 mm x 7 cmAR-6593-05-07159570ar2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmAR-6593-05-09159590ar2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmAR-6593-07-07159770ar2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmAR-6593-07-09159790ar2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmAR-6593-09-07159970ar2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmAR-6593-09-09159990ar2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22