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LOOP™ LED Curing Light
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref CLA05Ref CLA03Ref CLA02
Identity
- Trade Name
- LOOP™ LED Curing Light EUDAMEDFDA UDILoop™ Calibration and Charging Base FDA UDILoop™ FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- LOOP™ LED Curing Light EUDAMEDLOOP™ LED Curing Light-Sample FDA UDILoop™ Calibration and Charging Base Calibration and Charging Base FDA UDILoop™ Protective Barrier Sleeves FDA UDILoop™ Battery Kit FDA UDI
- Model / Reference
- CLA02 EUDAMEDFDA UDICLA05 EUDAMEDFDA UDICLA03 EUDAMEDFDA UDICLK01-R FDA UDI
- Description
- LOOP™ LED Curing Light-Sample FDA UDILoop™ Calibration and Charging Base Calibration and Charging Base FDA UDILoop™ Protective Barrier Sleeves FDA UDILoop™ Battery Kit FDA UDI
Identifiers
- Catalog Number
- CLK01-R FDA UDICLA02 FDA UDICLA05 FDA UDICLA03 FDA UDI
- Primary DI / UDI-DI
- 00810038093536 EUDAMEDFDA UDI00810038093550 EUDAMEDFDA UDI00810038093567 EUDAMED00810038091464 FDA UDI20810038093561 FDA UDI
- Basic UDI-DI
- 081003809CLK01SR EUDAMED
- 510(k) Number
- K200775 FDA UDI
- FDA Product Code
- EJL FDA UDIEBZ 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 EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 872.3240 FDA UDI872.6070 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA 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
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
Category: Dental/surgical polymerization lamp
LOOP™ LED Curing Light by Garrison Dental Solutions, L.l.c. — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions, L.l.c.
Sources (7)
- FDA UDI 740380e8-5673-4a87-91dd-d44a42d808bd 35 fields · synced Aug 1, 2026
- FDA UDI 743a99e7-a744-4a8e-925c-c7eb7a273dbb 36 fields · synced May 30, 2026
- FDA UDI 2d2f0ec4-5ef4-40c0-80f0-0f482b5218e6 34 fields · synced May 30, 2026
- FDA UDI 5c02c912-37a4-43ae-80e9-595c81d8eb84 35 fields · synced May 30, 2026
- EUDAMED 553c12a2-a01a-45f4-a8fe-f271f0a6cd97 61 fields · synced Jul 9, 2026
- EUDAMED 911279b2-8fc5-4511-8963-a2db98bdb971 61 fields · synced Jul 31, 2026
- EUDAMED a3190d18-d7c6-4076-a32c-284e37268a97 61 fields · synced Aug 1, 2026