Identity
- Trade Name
- Abiding Couple Lab Analog EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment analog, laboratory FDA UDI
- Device Name
- Abiding Couple Lab Analog EUDAMED
- Model / Reference
- ACLA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020804082 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800020804082 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant abutment analog, laboratory FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Italy 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
Abiding Couple Lab Analog by SNUCONE Co., LTD. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800020804082 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Snucone Co., Ltd.
- EUDAMED SRN
- KR-MF-000036358
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 7472f6a8-f7ba-4364-a3e3-cad36075f026 61 fields · synced Jun 19, 2026
- FDA UDI f72a0425-8982-4089-af8c-befc0723d619 32 fields · synced May 30, 2026