Identity
- Trade Name
- Titan Implant FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Screw Type Implant, 3.5 mm Diameter, 10 mm lengh FDA UDI
- Model / Reference
- I2-3.5,10 FDA UDI
- Description
- Screw Type Implant, 3.5 mm Diameter, 10 mm lengh FDA UDI
Identifiers
- Catalog Number
- I2-3.5,10 FDA UDI
- Primary DI / UDI-DI
- 07290107270007 FDA UDI
- 510(k) Number
- K132125 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDIOuter Diameter — 3.5 Millimeter FDA UDI
Category: Screw endosteal dental implant, two-piece
Titan Implant by A.b. Dental Devices Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K132125 also covers:
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
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
- A.b. Dental Devices Ltd
Sources (1)
- FDA UDI e34188a6-04d7-4514-b3e4-ae2cf9fdb04d 37 fields · synced Jun 8, 2026