Device Explorer · FDA GUDID · GMDN 35700

Facebow

A 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 d

US‑registered devices211in commercial distribution
Companies16labelers on GUDID
Single‑use10%of device records
Sterile0%labelled sterile
Prescription48%Rx‑only share
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Share of device records

Precision Dental Products Llc9846%
Zebris Medical Gmbh2914%
Devemed Gmbh189%
Amann Girrbach Ag136%
Novo Surgical, Inc.126%
Whip-Mix Corporation115%
Kohler Medizintechnik Gmbh73%
Ivoclar Vivadent Aktiengesellschaft73%

Top labelers

CompanyDevicesShare
Precision Dental Products Llc9846%
Zebris Medical Gmbh2914%
Devemed Gmbh189%
Amann Girrbach Ag136%
Novo Surgical, Inc.126%
Whip-Mix Corporation115%
Kohler Medizintechnik Gmbh73%
Ivoclar Vivadent Aktiengesellschaft73%
Kavo Dental Gmbh31%
Bayer Medical Care Inc.31%
B. Ali Impex31%
Clinician'S Choice Dental Products, Inc.21%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HeatWave™ CalipersSymmetry Facial Plain relator Sample PackARCUS digma USBARCUSevoARCUSKOHDENTArtexaccessoryReicodentdevemedUTS CADGnathometer CADUniversal Transferbogen System 3DGnathometer M mit UTS AdapterOneBite EvolutionFacial Plane Relator

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EHYTray, Impression, Preformed101
NFSDevice, Jaw Tracking, For Monitoring Jaw Positions45
KCRFacebow30
EILGauge, Depth, Instrument, Dental18
FTYTAPE, MEASURING, RULERS AND CALIPERS7
KCRFACEBOW6

GMDN & GCC registration

  • GMDN code 35700 · non‑implantable
  • Single‑use 10% · sterile 0% · Rx‑only 48% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many facebow products are registered in the US?

211 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Facebow", from 16 companies. The largest labeler is Precision Dental Products Llc with 46% of records.

Which FDA product codes apply?

EHY (Tray, Impression, Preformed), NFS (Device, Jaw Tracking, For Monitoring Jaw Positions), KCR (Facebow), EIL (Gauge, Depth, Instrument, Dental)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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