ACU-flow RIGID-TRAY

GUDID D811RIGIDTRAYRB4010

An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Rainbow Specialty & Health Products Inc

Silicone dental impression material Silicone dental impression material
Primary Device IDD811RIGIDTRAYRB4010
NIH Device Record Key93031344-de8f-4844-b424-5f171d7da10d
Commercial Distribution StatusIn Commercial Distribution
Brand NameACU-flow RIGID-TRAY
Version Model NumberRB401
Company DUNS206962040
Company NameRainbow Specialty & Health Products Inc
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 Usetrue
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

Device Dimensions

Total Volume50 Milliliter
Total Volume50 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD811RIGIDTRAYRB4010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-15

Devices Manufactured by Rainbow Specialty & Health Products Inc

D811ACUFLOWMX2610 - Acu-Flow Temporary Matrix Material2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
D811BALANCEBITEBR8120 - Balance-Bite Bite Registration2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
D811HARDBESTBITEBR8050 - BEST-BITE BITE REGISTRATION2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
D811HARDBITEBR8010 - ACU-flow BITE REGISTRATION2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
D811HEAVYBODYHB7010 - ACU-flow HEAVY BODY2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
D811LIGHTBODYPLUSLB6010 - ACU-flow LIGHT BODY PLUS2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
D811LIGHTBODYREGLBR5010 - LIGHT BODY - REGULAR FLOW2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
D811MEDIUMBODYMB3010 - ACU-flow MEDIUM BODY2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct

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