Unit Assembly 9645 FB

GUDID D04020011540

A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device.

WHIP-MIX CORPORATION

Facebow

• Primary Device ID: D04020011540
• NIH Device Record Key: a9575ac6-b302-4b41-ad7d-44a6c656f9ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unit Assembly 9645 FB
• Version Model Number: 20011540
• Company DUNS: 006385173
• Company Name: WHIP-MIX CORPORATION
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D04020011540 [Primary]

FDA Product Code

• KCR: Facebow

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: 2023-11-06
• Device Publish Date: 2023-10-27

Devices Manufactured by WHIP-MIX CORPORATION

• D040022720 - #2240Q ART/#8645 FACE BOW IN BOX: 2025-09-19 02272-S-#2240Q ART/#8645 FACE BOW IN BOX
• D040342160 - MA2340 W/STRAPS: 2025-09-19 34216-MA2340 W/STRAPS
• D040159110 - Quick mount Facebow: 2025-09-12 #8645 QUICK MOUNT FACE BOW W/SCREWS
• D040711830 - VeriFIT Splint: 2025-09-12 3D printing Thermo adaptive Splint resin
• D040711810 - VeriTray: 2024-04-30 VeriTray Turquoise - Impression Tray
• D040711820 - Veri DENT Tryin: 2024-04-26
• D040200113770 - Denar Mark 310 Articulator: 2024-03-06 A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosi
• D040200113780 - Denar Mark 320 Articulator: 2024-03-06 A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosi