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Dynamic Abutment® Solutions
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 34.613.186.01-2
Identity
- Trade Name
- DYNAMIC ABUTMENT® SOLUTIONS FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- ANALOG EUDAMEDDigital analog. Comp.0186 FDA UDI
- Model / Reference
- 34.613.186.01-2 EUDAMEDFDA UDI
- Description
- Digital analog. Comp.0186 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435673502773 EUDAMEDFDA UDI
- Basic UDI-DI
- 843656873ACCRES084Y EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant analog 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
No
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: Dental implant analog
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 Dental implant analog.
- Digital Lab Analog Screw — DENTIS CO. , LTD · Class I
- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM — DIO Corporation · Class I
- One Stage TL S — I3 IMPLANT LLC · Class II
- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
- Implant Analog 6mm Trilobe Stainless Steel — Sterngold Dental 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 |
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Manufacturer
- Manufacturer
- Talladium España Sl
Sources (2)
- FDA UDI 7033308b-c09b-484e-8db6-0fbd12c089cb 35 fields · synced Jul 24, 2026
- EUDAMED aa9f2597-c5d2-46d0-bcc4-2c4a7b03381d 61 fields · synced Jul 24, 2026