Identity
- Trade Name
- GLO MOUTHGUARD - PINK (DZ) *I FDA UDI
- Generic Name
- Mouthguard, reusable FDA UDI
- Device Name
- Mouthguard Preformed EUDAMEDGLO MOUTHGUARD - PINK (DZ) *I FDA UDI
- Model / Reference
- 191-021 EUDAMEDFDA UDI
- Description
- GLO MOUTHGUARD - PINK (DZ) *I FDA UDI
Identifiers
- Catalog Number
- 191-021 FDA UDI
- Primary DI / UDI-DI
- +D7751910211 EUDAMEDD7751910211 FDA UDI
- Basic UDI-DI
- ++D7751910218R EUDAMED
- FDA Product Code
- DYJ FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Mouthguard, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Mouthguard Preformed by Great Lakes Dental Technologies — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D7751910218R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes Dental Technologies
- EUDAMED SRN
- US-MF-000003408
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a9d89f82-8908-4340-b016-22c6028191c4 61 fields · synced Jun 19, 2026
- FDA UDI 3fe6ea13-0368-418c-b69e-ad878ea3ae51 35 fields · synced May 30, 2026