Identity
- Trade Name
- Gelato Prophy Paste EUDAMEDGELATO FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Prophy Paste EUDAMEDPROPHY PASTE CUPS CRS PINA X200 FDA UDI
- Model / Reference
- 24-03177 EUDAMEDFDA UDI
- Description
- PROPHY PASTE CUPS CRS PINA X200 FDA UDI
Identifiers
- Catalog Number
- 24-03177 FDA UDI
- Primary DI / UDI-DI
- ++H66824031771 EUDAMEDH66824031771 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
- Weight — 400 Gram FDA UDITotal Volume — 14.1 Fluid Ounce FDA UDI
Category: Dentifrice
Gelato by Keystone Industries — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- Topex® Prophy Paste — Dentsply International · Class I
- Disposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed — Premium Plus (Dongguan) Limited · Class IIa
- Dental City — ICP, INC. · Class I
- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · Class I
- Disposable Prophy Cups, CA Plastic Shank, Ribbed & Webbed Standard — Premium Plus (Dongguan) Limited · Class IIa
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
- Keystone Industries
Sources (2)
- FDA UDI ca85abaf-431d-4779-9bb5-608afd716147 37 fields · synced Jun 18, 2026
- EUDAMED 44775e35-3467-4892-b12c-3f78c535a31b 61 fields · synced Jun 18, 2026