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MEDRAD® TMJ Positioning Device and Mouthpeices

FDA UDI

Class II (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name
MEDRAD® TMJ Positioning Device and Mouthpeices FDA UDI
Generic Name
Facebow FDA UDI
Device Name
" TMJ Device Disposable Mouth Pieces (MOUTHPIECES,REPLACEMENT,TMJ,MC) (85104470)" FDA UDI
Model / Reference
TMJ 250 FDA UDI
Description
" TMJ Device Disposable Mouth Pieces (MOUTHPIECES,REPLACEMENT,TMJ,MC) (85104470)" FDA UDI

Identifiers

Catalog Number
TMJ 250 FDA UDI
Primary DI / UDI-DI
00616258009315 FDA UDI
510(k) Number
K870243 FDA UDI
FDA Product Code
EAG FDA UDI
GMDN Term
Facebow FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1830 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Facebow

MEDRAD® TMJ Positioning Device and Mouthpeices by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Facebow.

Cleared under the same submission

K870243 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bayer Medical Care Inc.

Sources (1)

  • FDA UDI 38ac0f09-aa36-4fc1-a8fc-549c0bfa9895 36 fields · synced Jun 9, 2026