Balance-Bite Bite Registration

GUDID D811BALANCEBITEBR8120

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

• Primary Device ID: D811BALANCEBITEBR8120
• NIH Device Record Key: 8b93318e-95ab-4d0f-975c-ab16f385ca2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balance-Bite Bite Registration
• Version Model Number: BR812
• Company DUNS: 206962040
• Company Name: Rainbow Specialty & Health Products 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: false
• 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 Dimensions

• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D811BALANCEBITEBR8120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053018

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-09

Devices Manufactured by Rainbow Specialty & Health Products Inc

• D811ACUFLOWMX2610 - Acu-Flow Temporary Matrix Material: 2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
• D811BALANCEBITEBR8120 - Balance-Bite Bite Registration: 2018-07-06An 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.
• D811BALANCEBITEBR8120 - Balance-Bite Bite Registration: 2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
• D811HARDBESTBITEBR8050 - BEST-BITE BITE REGISTRATION: 2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
• D811HARDBITEBR8010 - ACU-flow BITE REGISTRATION: 2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
• D811HEAVYBODYHB7010 - ACU-flow HEAVY BODY: 2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
• D811LIGHTBODYPLUSLB6010 - ACU-flow LIGHT BODY PLUS: 2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
• D811LIGHTBODYREGLBR5010 - LIGHT BODY - REGULAR FLOW: 2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct
• D811MEDIUMBODYMB3010 - ACU-flow MEDIUM BODY: 2018-07-06 An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the struct