Identity
- Trade Name
- ItsoClear EUDAMEDFDA UDI
- Generic Name
- Denture clasp, polymer, preformed FDA UDI
- Device Name
- ItsoClear Clasps EUDAMEDClear Molar Clasps (2.2 mm) 36/pkg FDA UDI
- Model / Reference
- 1009153 EUDAMEDFDA UDI
- Description
- Clear Molar Clasps (2.2 mm) 36/pkg FDA UDI
Identifiers
- Catalog Number
- 1009153 FDA UDI
- Primary DI / UDI-DI
- ++H66810091531 EUDAMEDH66810091531 FDA UDI
- Basic UDI-DI
- ++H668CLASP0015A EUDAMED
- FDA Product Code
- EHP FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Denture clasp, polymer, preformed FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3285 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 2.2 Millimeter FDA UDI
ItsoClear by Keystone Industries — 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 | ++H668CLASP0015A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keystone Industries
- EUDAMED SRN
- US-MF-000020203
- Authorised Representative
- KEYSTONE Europe BV NL-AR-000010443
Sources (2)
- EUDAMED 3795841e-c5d2-43aa-b197-2506a02b87ef 61 fields · synced Jun 9, 2026
- FDA UDI cee120bd-67da-4a47-b879-e112486bb46e 36 fields · synced May 30, 2026