Identity
- Trade Name
- 5PK BLK HI PULL HEAD CAP *O FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- Extraoral Headgear EUDAMED5PK BLK HI PULL HEAD CAP *O FDA UDI
- Model / Reference
- 300-107 EUDAMEDFDA UDI
- Description
- 5PK BLK HI PULL HEAD CAP *O FDA UDI
Identifiers
- Catalog Number
- 300-107 FDA UDI
- Primary DI / UDI-DI
- +D7753001070 EUDAMEDD7753001070 FDA UDI
- Basic UDI-DI
- ++D7751550288P EUDAMED
- FDA Product Code
- DZB FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic extraoral headgear FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5500 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
Yes
FDA UDI
Extraoral Headgear 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 | ++D7751550288P | 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 5d46914f-211d-4730-b35b-a717cc4c3ccd 61 fields · synced Jul 9, 2026
- FDA UDI 4e38c30f-2c69-4a59-8764-7f1a1363faf1 35 fields · synced May 25, 2026