FDA.reportPublic FDA data

MEDRAD® TMJ Positioning Device and Mouthpeices

Primary DI
10616258009312
Brand
MEDRAD® TMJ Positioning Device and Mouthpeices
Company
BAYER MEDICAL CARE INC.
Model
TMJ 250
Catalog number
TMJ 250
Device description
" TMJ Device Disposable Mouth Pieces (MOUTHPIECES,REPLACEMENT,TMJ,MC) (85104470)"
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAGCephalometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAGCephalometerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870243000BURNETT TMJ APPLIANCEMedrad, Inc.1987-02-24EAG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10616258009312PackageGS110In Commercial Distribution
00616258009315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061625800931210616258009312
00616258009315006162580093156162580093150616258009315

GMDN Terms#

Term, Definition table
TermDefinition
FacebowA caliper-like dental device intended for use in denture fabrication to record the relative position of the maxillary arch to the temporomandibular joint (TMJ), or the spatial relationship between the upper and lower jaws. This determination is intended for use in placing denture casts accurately into an articulator and thereby aiding correct placement of artificial teeth into a denture base. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-7231ricustomercomplaints@bayer.com

Regulatory Flags#

DUNS number
058716649
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616258007243200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258007526200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258024325MEDRAD® MRXperion Sterile Disposable MRI KitXP 65/115VSXP 65/115VS2024-05-06
00616258027340Imaging System Interface - ISI2 ModuleISI2ISI22024-06-17
00616258025094MEDRAD® MRXperion MR Injection SystemMRXP 200MRXP 2002024-05-06
00616258026206MEDRAD® MRXperion MR Injection System HandswitchSSMR STARTSSMR START2022-04-22
00616258010090200mL Sterile Disposable Qwik-Fit Syringe & QFT 200-FLS-Q 200-FLS-Q 2019-05-20
00616258005492200mL Sterile Disposable Qwik-Fit Syringe & QFT200-FLS-Q200-FLS-Q2016-09-24
00616258008165MEDRAD® MRXperion MR Injection SystemSSMR STARTSSMR START2016-09-24
00616258008943MEDRAD® Stellant CT Injection SystemStellant D-CESCT-310, SCT-321, SCT-3222016-09-24
00616258021249MEDRAD® VFLOW Sterile Disposable Hand ControllerVF HCVF HC2025-12-19
00616258020419MEDRAD® Mark 7 Arterion Injection SystemARTERION BASE SYSTEMARTERION BASE SYSTEM2025-12-19
40616258021247MEDRAD® VFLOW Sterile Disposable Hand ControllerVF HCVF HC2025-12-19
00616258025186MEDRAD® Stellant CT Injection SystemSCT-310, SCT-321, SCT-322SCT-310, SCT-321, SCT-3222025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationFLEXFLEX2025-12-10
00616258025131MEDRAD® Stellant CT Injection SystemSCT-310, SCT-321, SCT-322SCT-310, SCT-321, SCT-3222024-11-01
00616258010229Avanta Hand Controller SheathAVA 500 HCSAVA 500 HCS2019-05-20
00616258010236Display Control Unit Sheath AVA 500 DCOV AVA 500 DCOV 2019-05-20
00616258021546Avanta Hand Controller SheathAVA 500 HCSAVA 500 HCS2019-10-25
00616258021553Display Control Unit Sheath AVA 500 DCOV AVA 500 DCOV 2019-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00616258009315MEDRAD® TMJ Positioning Device and MouthpeicesBAYER MEDICAL CARE INC.EAG2016-12-22
00616258009339MEDRAD® TMJ Positioning Device and MouthpeicesBAYER MEDICAL CARE INC.EAG2016-12-22
00616258009322MEDRAD® TMJ Positioning Device and MouthpeicesBAYER MEDICAL CARE INC.EAG2016-09-24