Identity
- Trade Name
- DYNAMIC ABUTMENT SOLUTIONS FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- Dynamic Screw M2 L9.0mm 25Ncm FDA UDI
- Model / Reference
- 41.320.090.01-2 FDA UDI
- Description
- Dynamic Screw M2 L9.0mm 25Ncm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436568732015 FDA UDI
- 510(k) Number
- K232151 FDA UDI
- FDA Product Code
- NHA 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
MR Conditional FDA UDI
Category: Dental prosthesis/implant abutment screw
Dynamic Abutment Solutions by Talladium España 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
- 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
- Recharge Kit w/ POC, TiLobe — SMART DENTURE CONVERSIONS, LLC · Class I
Cleared under the same submission
K232151 also covers:
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA 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 |
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Manufacturer
- Manufacturer
- Talladium España Sl
Sources (1)
- FDA UDI aabd3f3a-7f12-4442-8477-b534f472b68b 36 fields · synced Jun 1, 2026