Identity
- Trade Name
- IPD FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- Screw For MUA 1.4 (Blue) - Elemental Ref: EZA14 FDA UDI
- Model / Reference
- TT FDA UDI
- Description
- Screw For MUA 1.4 (Blue) - Elemental Ref: EZA14 FDA UDI
Identifiers
- Catalog Number
- IPD/AB-TR-01 FDA UDI
- Primary DI / UDI-DI
- 08435566643002 FDA UDI
- 510(k) Number
- K222215 FDA UDI
- FDA Product Code
- NHA FDA UDIPNP FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental prosthesis/implant abutment screw
Ipd by Implant Protesis Dental 2004 Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
Cleared under the same submission
K222215 also covers:
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
- IPD — IMPLANT PROTESIS DENTAL 2004 SL
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implant Protesis Dental 2004 Sl
Sources (1)
- FDA UDI 89c208c7-d339-41f8-945e-12b233ebb5c6 36 fields · synced Jun 1, 2026