Orthodontic Relief Wax

GUDID D8199008909

SPECIALTY APPLIANCES, LLC

Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material Wax dental impression material

• Primary Device ID: D8199008909
• NIH Device Record Key: 206bb863-65ea-450c-a917-a59239cc33a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthodontic Relief Wax
• Version Model Number: 900890
• Company DUNS: 106645484
• Company Name: SPECIALTY APPLIANCES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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
HIBCC	D8199008900 [Primary]
HIBCC	D8199008909 [Package]; Contains: D8199008900; Package: [144 Units]; In Commercial Distribution

FDA Product Code

• EGD: Wax, Dental, Intraoral

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-13
• Device Publish Date: 2024-03-05

Devices Manufactured by SPECIALTY APPLIANCES, LLC

• D8199006250 - Upper ROC Kit for Herbst: 2024-04-30
• D8199006260 - Lower ROC Kit for Herbst: 2024-04-30
• D8199006270 - Upper Crown Kit for Herbst: 2024-04-30
• D8199006280 - Lower Crown Kit for Herbst: 2024-04-30
• D8199006290 - ROC Kit: 2024-04-30
• D8199006300 - Crown Kit: 2024-04-30
• D8199013170 - OnBrace Kit: 2024-04-30
• D8199013182 - OnBrace Crown UR2 (5/pk): 2024-03-18