FDA.reportPublic FDA data

accessory

Primary DI
E4942176951
Brand
accessory
Company
Amann Girrbach AG
Model
Nasion adapter, blue
Catalog number
217695
Published
2022-09-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCRFacebow

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E4942176951PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+43552363330austria@amanngirrbach.com

Regulatory Flags#

DUNS number
300708950
Device count
1
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E4947610871Ceramill A-SplintCeramill A-Splint 98x14/107610872026-01-21
E4947610881Ceramill A-SplintCeramill A-Splint 98x16/107610882026-01-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040022720#2240Q ART/#8645 FACE BOW IN BOXWHIP-MIX CORPORATIONKCR2025-09-11
07615208459579UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
07615208460483UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
06973329326059Reverse Pull Headgear(Face Mask), Middle, RedAstar Orthodontics Inc.KCR2023-12-31
06973329326066Reverse Pull Headgear(Face Mask), Middle, BlueAstar Orthodontics Inc.KCR2023-12-31
06973329326073Reverse Pull Headgear(Face Mask), Middle, YellowAstar Orthodontics Inc.KCR2023-12-31
06973329326080Reverse Pull Headgear(Face Mask), Middle, OrangeAstar Orthodontics Inc.KCR2023-12-31
06973329326097Reverse Pull Headgear(Face Mask), Middle, PurpleAstar Orthodontics Inc.KCR2023-12-31
06973329326103Reverse Pull Headgear(Face Mask), Middle, GreenAstar Orthodontics Inc.KCR2023-12-31
G586E8310210Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310220Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310310Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310320Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310330Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
E1996624511Bite forkCandulor AGKCR2023-11-16
E1996624531Bite fork SetCandulor AGKCR2023-11-16
E1996625131CRS Set 10Candulor AGKCR2023-11-16
D04020002950Unit-Assy SlidematicWHIP-MIX CORPORATIONKCR2023-10-27
D04020011540Unit Assembly 9645 FBWHIP-MIX CORPORATIONKCR2023-10-27
00850211006144Facial Plane RelatorHO DENTAL COMPANY LLCKCR2023-05-17
00842331179730Novo Surgical Inc. NOVO SURGICAL, INC.KCR2022-11-14
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E4942186351accessoryAmann Girrbach AGKCR2022-09-07
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E4942176611accessoryAmann Girrbach AGKCR2022-08-22
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