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Implant Indicator
FDA UDIClass II (US FDA UDI)
by T.a.g Medical Products Agricultural Cooperative Association
Identity
- Trade Name
- Implant Indicator FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Model / Reference
- B FDA UDI
Identifiers
- Catalog Number
- TK1-0013 FDA UDI
- Primary DI / UDI-DI
- 10810190012915 FDA UDI
- 510(k) Number
- K143326 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant system
Implant Indicator by T.a.g Medical Products Agricultural Cooperative Association — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
- Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
Cleared under the same submission
K143326 also covers:
- 1/4" Abutment Fixture Short — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 15° Esthetic Abutment H1mm Ti — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 15° Esthetic Abutment H2mm Burn-Out — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 2.42 Retriever Key — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 25° Angulated Abutment H2mm Ti Wide — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 25° Esthetic Abutment H3mm Burn-Out — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 25° Temporary Abutment H1mm PEEK — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Abutment H1mm L6mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Abutment H1mm L8mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Abutment H2mm L4mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Abutment H3mm L6mm Wide — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Healing Cap 4mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 24515834-8b1e-4ffc-a9fd-c66dbc45d465 34 fields · synced Jun 1, 2026