TMJ Solutions, Inc.

Address:6059 King Drive,San Buenaventura,CA,93003,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Joint, Temporomandibular, Implant (LZD) (9)

Premarket Exempt

Clear

Patient-Fitted TMJ Reconstructive Prosthesis System - B004TYYNNNNLM0 Catalog Number :

Device Description : Left Mandibular Component

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B004TYYNNNNM0 Catalog Number :

Device Description : Anatomical Bone Model

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B004TYYNNNNRF0 Catalog Number :

Device Description : Right Fossa Component

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B004TYYNNNNRM0 Catalog Number :

Device Description : Right Mandibular Component

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B004YYMMDDNNNNLF0 Catalog Number :

Device Description : Left Fossa Component

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B004YYMMDDNNNNLM0 Catalog Number :

Device Description : Left Mandibular Component

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B004YYMMDDNNNNM0 Catalog Number :

Device Description : Anatomical Bone Model

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B004YYMMDDNNNNRF0 Catalog Number :

Device Description : Right Fossa Component

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B004YYMMDDNNNNRM0 Catalog Number :

Device Description : Right Mandibular Component

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

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