FDA.reportPublic FDA data

Quick mount Facebow

Primary DI
D040159110
Brand
Quick mount Facebow
Company
WHIP-MIX CORPORATION
Model
15911
Device description
#8645 QUICK MOUNT FACE BOW W/SCREWS
Published
2025-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KRCTester, Electrode, Surface, Electrocardiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRCTester, Electrode, Surface, ElectrocardiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D040159110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
FacebowA caliper-like dynamic dental instrument 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 determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006385173
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D040600001ARDENT600002025-11-05
D040600011ARDENT600012025-11-05
D040600071ARDENT600072025-11-05
D040600081ARDENT 600082023-10-27
D040602061ARDENT 602062023-10-27
D040600021ARDENT DISPOSABLE DENT600022023-08-18
D040600031ARDENT DISPOSABLE DENT600032023-08-18
D040603000Forceps- Paper603002023-08-18
D0406010072Articulating paper/film60100601002020-08-24
D0406010160Articulating paper/film60101601012020-08-24
D0406020075Articulating paper/film60200602002020-08-24
D0406020175Articulating paper/film60201602012020-08-24
D0406020275Articulating paper/film60202602022020-08-24
D04060002140Articulating paper/film60002600022020-08-17
D04060003140Articulating paper/film60003600032020-08-17
D04060004140Articulating paper/film60004600042020-08-17
D04060005144Articulating paper/film60005600052020-08-17
D04060006144Articulating paper/film60006600062020-08-17
D040022720#2240Q ART/#8645 FACE BOW IN BOX02272-S2025-09-11
D040342160MA2340 W/STRAPS342162025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHKRC2018-12-18
20884838072248Spirometry SensorPhilips Medizin Systeme Böblingen GmbHKRC2017-01-20
00862186000300GDGeneral DevicesKRC2016-09-23
00862186000317GDGeneral DevicesKRC2016-09-23