FDA.report

Artex

Primary DI
E49A21765010
Brand
Artex
Company
Amann Girrbach AG
Model
Artex Quickbite, 10 pcs
Catalog number
217650
Published
2022-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KCRFacebow

Product Code Classifications

CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E49A21765010PrimaryHIBCC0
E49A2176501001Unit of UseHIBCC0

GMDN Terms

TermDefinition
FacebowA 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 determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+43552363330austria@amanngirrbach.com

Regulatory Flags

DUNS number
300708950
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

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E4947610891Ceramill A-SplintCeramill A-Splint 98x20/107610892026-01-21
E4947682361Zolid Bion Zolid Bion BL2 98x12 F7682362025-02-25
E4947682391Zolid Bion Zolid Bion BL2 98x18 F7682392025-02-25
E4947682411Zolid Bion Zolid Bion BL2 98x25 F7682412025-02-25
E4947682421Zolid Bion Zolid Bion BL2 98x30 F7682422025-02-25
E4947682521Zolid Bion Zolid Bion BL4 98x12 F7682522025-02-25
E4947682551Zolid Bion Zolid Bion BL4 98x18 F7682552025-02-25
E4947682571Zolid Bion Zolid Bion BL4 98x25 F7682572025-02-25
E4947682581Zolid Bion Zolid Bion BL4 98x30 F7682582025-02-25
E4947682981Zolid Bion Zolid Bion A4 98x30 F7682982025-02-25
E4947683161Zolid Bion Zolid Bion B3 98x12 F7683162025-02-25
E4947683191Zolid Bion Zolid Bion B3 98x18 F7683192025-02-25
E4947683211Zolid Bion Zolid Bion B3 98x25 F7683212025-02-25
E4947683221Zolid Bion Zolid Bion B3 98x30 F7683222025-02-25
E4947683241Zolid Bion Zolid Bion B4 98x12 F7683242025-02-25
E4947683271Zolid Bion Zolid Bion B4 98x18 F7683272025-02-25
E4947683291Zolid Bion Zolid Bion B4 98x25 F7683292025-02-25
E4947683301Zolid Bion Zolid Bion B4 98x30 F7683302025-02-25

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E4942176611accessoryAmann Girrbach AGKCR2022-08-22
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