Identity
- Trade Name
- Perfectim Final Wash FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- PVS Dental Impression Material FDA UDI
- Model / Reference
- 21300800 FDA UDI
- Description
- PVS Dental Impression Material FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10852253006080 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 Final Wash 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
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- 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 30 Second SnoWhite — 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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- J. Morita U.s.a., Inc
Sources (1)
- FDA UDI 5917c7aa-3d72-44d0-a4ca-15b745a1c421 34 fields · synced Jun 1, 2026