Identity
- Trade Name
- Perfectim 30 Second SnoWhite FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- PVS Dental Impression Material FDA UDI
- Model / Reference
- 21300925 FDA UDI
- Description
- PVS Dental Impression Material FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10852253006035 FDA UDI
- 510(k) Number
- K964692 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Silicone dental impression material
Perfectim 30 Second SnoWhite by J. Morita U.s.a., Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
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- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Cleared under the same submission
K964692 also covers:
- Perfectim 30 Second Blue Velvet — J. MORITA U.S.A., INC
- Perfectim 30 Second Flexi-Velvet — J. MORITA U.S.A., INC
- Perfectim 90 Second Blue Velvet — J. MORITA U.S.A., INC
- Perfectim 90 Second Flexi-Velvet — J. MORITA U.S.A., INC
- Perfectim 90 Second SnoWhite — J. MORITA U.S.A., INC
- Perfectim Final Wash — J. MORITA U.S.A., INC
- Perfectim Putty Type Kit — J. MORITA U.S.A., INC
- Perfectim Single Phase Body — J. MORITA U.S.A., INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- J. Morita U.s.a., Inc
Sources (1)
- FDA UDI 770fa4fe-5e36-44d0-93ad-3986df6e9339 34 fields · synced Jun 6, 2026