Polysil Medium Viscosity Regular Set SH-102

GUDID 17540196000502

Dental impression material to reproduce the structure of a patient's teeth and gums. Packaged in a cartridge system. Medium viscosity, regular set.

Scican Ltd

Silicone dental impression material
Primary Device ID17540196000502
NIH Device Record Key7b0803f3-2d40-488d-a88a-8888e7b8c3e9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolysil Medium Viscosity Regular Set
Version Model NumberSH-102
Catalog NumberSH-102
Company DUNS204137145
Company NameScican Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18006677733
Emailtboyce@scican.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature (65°-73°F / 18°-23°C).

Device Identifiers

Device Issuing AgencyDevice ID
GS107540196000505 [Primary]
GS117540196000502 [Package]
Contains: 07540196000505
Package: Carton [2 Units]
In Commercial Distribution

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-02

Devices Manufactured by Scican Ltd

07540196003179 - STATIM 5000 G4 Cassette Autoclave2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber
07540196003186 - STATIM 5000 G4 Cassette Autoclave2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber (Loaner)
07540196003193 - STATIM 5000 G4 Cassette Autoclave2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber (Refurbished)
07540196002097 - BRAVO 17V Autoclave2023-06-13 Table-top steam sterilizer (Refurbished)
07540196002103 - BRAVO 17V Autoclave2023-06-13 Table-top steam sterilizer (Loaner)
07540196002110 - BRAVO 17V Autoclave2023-06-13 Table-top steam sterilizer (Loaner)
17540196002353 - Statcare spray2023-06-13 One step, pre-sterilization handpiece maintenance spray
17540196002360 - Statmatic spray2023-06-13 One step, pre-sterilization handpiece maintenance spray

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.