Identity
- Trade Name
- DYNAMIC ABUTMENT SOLUTIONS FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- DAS Multi-Unit Dynamic Screw, M2 L4mm 25Ncm FDA UDI
- Model / Reference
- 41.320.040.01-2 FDA UDI
- Description
- DAS Multi-Unit Dynamic Screw, M2 L4mm 25Ncm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436568733654 FDA UDI
- 510(k) Number
- K231559 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
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
K231559 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 389fd307-fa21-48dd-a172-97dfc41f6ff2 36 fields · synced May 30, 2026