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Perfectim Tissue Mimic

FDA UDI

Class II (US FDA UDI)

by J. Morita U.s.a., Inc

Identity

Trade Name
Perfectim Tissue Mimic FDA UDI
Generic Name
Silicone dental impression material FDA UDI
Device Name
PVS Dental Impression Material FDA UDI
Model / Reference
21301100 FDA UDI
Description
PVS Dental Impression Material FDA UDI

Identifiers

Primary DI / UDI-DI
10852253006127 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
Not 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

Perfectim Tissue Mimic by J. Morita U.s.a., Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K964692 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
J. Morita U.s.a., Inc

Sources (1)

  • FDA UDI d5868966-3d52-4a3d-a311-5aa3a0dab652 35 fields · synced May 30, 2026