Perfectim Tissue Mimic

GUDID 10852253006127

PVS Dental Impression Material

J. MORITA U.S.A., INC

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

Primary Device ID	10852253006127
NIH Device Record Key	d5868966-3d52-4a3d-a311-5aa3a0dab652
Commercial Distribution Status	In Commercial Distribution
Brand Name	Perfectim Tissue Mimic
Version Model Number	21301100
Company DUNS	021866033
Company Name	J. MORITA U.S.A., INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10852253006127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K964692

FDA Product Code

ELW	Material, Impression

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-01-28
Device Publish Date	2016-09-22

On-Brand Devices [Perfectim Tissue Mimic ]

18522530060129	PVS Dental Impression Material
10852253006127	PVS Dental Impression Material