← Back to catalogue
Dynamic Abutment Solutions
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 71.340.153.01-2Model ACCKIT01
Identity
- Trade Name
- DYNAMIC ABUTMENT SOLUTIONS FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- GUIDE SLEEVE EUDAMEDGuide sleeve Øint.1.53mm (Anchor Pin) FDA UDI
- Model / Reference
- 71.340.153.01-2 EUDAMEDFDA UDIACCKIT01 EUDAMED
- Description
- Guide sleeve Øint.1.53mm (Anchor Pin) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435673506870 EUDAMEDFDA UDI
- Basic UDI-DI
- 843656873ACCKITJN EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, reusable 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
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: Surgical drill guide, reusable
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 Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 3a4f239b-af23-4510-9af2-1d4a5b9345df 35 fields · synced Jun 18, 2026
- EUDAMED a9aa9c6a-093c-42e0-abfc-716ace06790d 61 fields · synced Jun 18, 2026