Unit-Assy Slidematic

GUDID D04020002950

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. CLOSE

WHIP-MIX CORPORATION

Facebow
Primary Device IDD04020002950
NIH Device Record Key5a3d213e-743c-4997-9baa-34033b595762
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnit-Assy Slidematic
Version Model Number20002950
Company DUNS006385173
Company NameWHIP-MIX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD04020002950 [Primary]

FDA Product Code

KCRFacebow

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-06
Device Publish Date2023-10-27

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