Identity
- Trade Name
- LOOP™ LED Curing Light EUDAMEDLoop™ FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- LOOP™ LED Curing Light EUDAMEDLoop™ Lens Cleaning Cloth FDA UDI
- Model / Reference
- CLA07 EUDAMEDFDA UDI
- Description
- Loop™ Lens Cleaning Cloth FDA UDI
Identifiers
- Catalog Number
- CLA07 FDA UDI
- Primary DI / UDI-DI
- 00810038090870 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809CLK01SR EUDAMED
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6070 FDA UDI
- 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
Category: Dental/surgical polymerization lamp
Loop™ by Garrison Dental Solutions, L.l.c. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions, L.l.c.
Sources (2)
- FDA UDI 1d8769fb-76f6-4ab8-a5c5-95ad123a7770 34 fields · synced Jul 16, 2026
- EUDAMED 6f5fff4c-7e48-427f-884d-02d0473f451b 61 fields · synced Jul 16, 2026