Identity
- Trade Name
- TITAN IMPLANTS, INC. FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- 2.0mm Post, 4.0mm Profile, 5.5mm Prep Ht, Gh 3mm FDA UDI
- Model / Reference
- BC-2453PA FDA UDI
- Description
- 2.0mm Post, 4.0mm Profile, 5.5mm Prep Ht, Gh 3mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842448100702 FDA UDI
- 510(k) Number
- K042971 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Titan Implants, Inc. by Titan Implant Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K042971 also covers:
- TITAN IMPLANTS INC — TITAN IMPLANT INC
- TITAN IMPLANTS INC — TITAN IMPLANT INC
- TITAN IMPLANTS INC — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC
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
- Manufacturer
- Titan Implant Inc
Sources (1)
- FDA UDI ea964aa4-1903-4634-b1c7-331ee7a5b729 34 fields · synced May 31, 2026