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Gelato Prophy Paste
EUDAMEDFDA UDIClass I (EU MDR)
Ref 24-02277Ref 24-11777Ref 24-11677Ref 24-05177Ref 24-02577
Identity
- Trade Name
- Gelato Prophy Paste EUDAMEDGELATO FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Prophy Paste EUDAMEDPROPHY PASTE CUPS CRS ORANGE X200 FDA UDIPROPHY PASTE CUPS MED MINT X200 FDA UDIPROPHY PASTE CUPS X-COARSE MINT X200 FDA UDIPROPHY PASTE CUPS MED ORANGE X200 FDA UDIPROPHY PASTE CUPS MED PINA X200 FDA UDI
- Model / Reference
- 24-02277 EUDAMEDFDA UDI24-11777 EUDAMEDFDA UDI24-05177 EUDAMEDFDA UDI24-11677 EUDAMEDFDA UDI24-02577 EUDAMEDFDA UDI
- Description
- PROPHY PASTE CUPS CRS ORANGE X200 FDA UDIPROPHY PASTE CUPS MED MINT X200 FDA UDIPROPHY PASTE CUPS X-COARSE MINT X200 FDA UDIPROPHY PASTE CUPS MED ORANGE X200 FDA UDIPROPHY PASTE CUPS MED PINA X200 FDA UDI
Identifiers
- Catalog Number
- 24-11777 FDA UDI24-02277 FDA UDI24-05177 FDA UDI24-11677 FDA UDI24-02577 FDA UDI
- Primary DI / UDI-DI
- ++H66824022771 EUDAMED++H66824117771 EUDAMED++H66824116771 EUDAMED++H66824051771 EUDAMED++H66824025771 EUDAMEDH66824117771 FDA UDIH66824022771 FDA UDIH66824051771 FDA UDIH66824116771 FDA UDIH66824025771 FDA UDI
- Basic UDI-DI
- ++H668PROPHY0012K EUDAMED
- FDA Product Code
- EJR FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dentifrice FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6030 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 14.1 Fluid Ounce FDA UDIWeight — 400 Gram FDA UDI
Gelato Prophy Paste 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 | ++H668PROPHY0012K | 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 (10)
- EUDAMED 934035bd-1f5f-4054-b758-5767a01d30e0 61 fields · synced Jul 31, 2026
- FDA UDI 6399b0ae-3e7d-40cf-9210-b2beb82bff63 37 fields · synced May 29, 2026
- FDA UDI b4d3e52c-3ee0-45b0-b3f9-8f073fd38340 37 fields · synced May 30, 2026
- FDA UDI 16205924-7f5a-4725-9450-10d87e0c58ce 37 fields · synced May 30, 2026
- FDA UDI f48d3557-6a1b-4a48-9389-4e48d47705dd 37 fields · synced May 30, 2026
- FDA UDI 2e6212ce-6703-4ed9-9ca4-011b8490c338 37 fields · synced May 30, 2026
- EUDAMED 904d1124-aa8d-4f1d-b660-8baa37fc2e4e 61 fields · synced Jul 13, 2026
- EUDAMED 178a9480-b78a-4276-8d7b-7ab0e5e516f3 61 fields · synced Jul 13, 2026
- EUDAMED 4acccfc3-25fb-4d83-b70d-a49e722a64da 61 fields · synced Jul 23, 2026
- EUDAMED 9aef0560-7cf9-4913-bfa6-18815f5d5f2f 61 fields · synced Jul 31, 2026