Polysil Transbite SH-301

GUDID 17540196000601

Transparent bite registraton material. Ideal for performing occlusal templates, labial matrices and other custom matrices for light cured materials.

Scican Ltd

Silicone dental impression material
Primary Device ID17540196000601
NIH Device Record Keyd571b48b-ea69-490a-b3e2-7b6206a8a1b6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolysil Transbite
Version Model NumberSH-301
Catalog NumberSH-301
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
GS107540196000604 [Primary]
GS117540196000601 [Package]
Contains: 07540196000604
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

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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

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