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Para-occlusal Attachment with Lip Arch

FDA UDI

Class I (US FDA UDI)

by zebris MEDICAL GmbH

Identity

Trade Name
Para-occlusal Attachment with Lip Arch FDA UDI
Generic Name
Facebow FDA UDI
Device Name
The Para-occlusal Attachment with Lip Arch is an accessory of the JMA-Optic and used to attach the lower jaw sensor to the teeth FDA UDI
Model / Reference
01960250 FDA UDI
Description
The Para-occlusal Attachment with Lip Arch is an accessory of the JMA-Optic and used to attach the lower jaw sensor to the teeth FDA UDI

Identifiers

Catalog Number
NA FDA UDI
Primary DI / UDI-DI
B915019602500 FDA UDI
FDA Product Code
NFS FDA UDI
GMDN Term
Facebow FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.2060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Facebow

Para-occlusal Attachment with Lip Arch by zebris MEDICAL GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Facebow.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
zebris MEDICAL GmbH

Sources (1)

  • FDA UDI c379f112-1ff2-4a18-bf74-a81cffae603a 35 fields · synced May 29, 2026