Dynamic Abutment Solutions
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- DYNAMIC ABUTMENT SOLUTIONS FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- SLEEVE GRIPPER EUDAMEDDAS Sleeve gripper FDA UDI
- Model / Reference
- 79.300.003.02-2 EUDAMEDFDA UDIACCKIT02 EUDAMED
- Description
- DAS Sleeve gripper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435673509925 EUDAMEDFDA UDI
- Basic UDI-DI
- 843656873ACCKIT0238 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Manual non-rotary dental instrument handle
Dynamic Abutment Solutions by Talladium España Sl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual non-rotary dental instrument handle.
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC. · Class I
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Medentika — Medentika GmbH · Class I
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- Implantium, Superline — Dentium Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Talladium España Sl
Sources (2)
- FDA UDI ab96a450-83d6-433a-a6f7-64fd1e257848 35 fields · synced Jul 9, 2026
- EUDAMED 587ed5a8-096f-47b3-8d70-caf7f6886c73 61 fields · synced Jul 9, 2026