FDA.reportPublic FDA data

Para-occlusal Attachment with Support Surface AG

Primary DI
B915019602560
Brand
Para-occlusal Attachment with Support Surface AG
Company
zebris MEDICAL GmbH
Model
01960256
Device description
"The Para-occlusal Attachment with Support Surface is an accessory of the ""zebris for ceramill"" facebowand used to attach the lower jaw sensor to the teeth."
Published
2023-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFSDevice, Jaw Tracking, For Monitoring Jaw PositionsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B915019602560PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4972319573400ts@amanngirrbach.com

Regulatory Flags#

DUNS number
328971791
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B915015705201Inductive Charger Tizian JMA-Optic01570520NA2023-10-04
B915015705401Inductive Charger ARCUSdigma III01570540NA2023-10-04
B915011700230Tizian JMA Optic USB01170023NA2023-07-20
B915011700410ARCUSdigma 3 USB01170041NA2023-07-20
B915015700231Tizian JMA Optic USB01570023NA2023-07-20
B915015700411ARCUSdigma 3 USB01570041NA2023-07-20
B915011700210Tizian JMA Optic01170021NA2021-02-18
B915011700400ARCUSdigma 301170040NA2021-02-18
B915015700211Tizian JMA Optic01570021NA2021-02-18
B915015700401ARCUSdigma 301570040NA2021-02-18
B915015705101Inductive Charger JMA-Optic01570510NA2023-10-04
B915015705501Inductive Charger zebris for ceramill01570550NA2023-10-04
B915015705701Inductive Charger PlaneAnalyser II01570570NA2023-10-04
B915012430050FDM-SX01243005NA2023-08-11
B915012430100FDM-S01243010NA2023-08-11
B915012430150FDM-1.501243015NA2023-08-11
B915012430200FDM-201243020NA2023-08-11
B915012430300FDM-301243030NA2023-08-11
B915015430051FDM-SX System01543005NA2023-08-11
B915015430101FDM-S System01543010NA2023-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970163085968SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-05-23
06970163087672SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-05-23
06970163084213SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-03-15
06970163081489MARATHON®Shining 3D Tech Co., Ltd.NFS2023-10-13
B915015705101Inductive Charger JMA-Opticzebris MEDICAL GmbHNFS2023-10-04
B915015705201Inductive Charger Tizian JMA-Opticzebris MEDICAL GmbHNFS2023-10-04
B915015705401Inductive Charger ARCUSdigma IIIzebris MEDICAL GmbHNFS2023-10-04
B915015705501Inductive Charger zebris for ceramillzebris MEDICAL GmbHNFS2023-10-04
B915015705701Inductive Charger PlaneAnalyser IIzebris MEDICAL GmbHNFS2023-10-04
06970163081229Opera System®Shining 3D Tech Co., Ltd.NFS2023-08-23
B915015700521zebris for ceramill USB-Lzebris MEDICAL GmbHNFS2023-07-24
B915011700230Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
B915011700410ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
B915011700510zebris for ceramill USBzebris MEDICAL GmbHNFS2023-07-20
B915011700720PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
B915015700131JMA Optic USB-Lzebris MEDICAL GmbHNFS2023-07-20
B915015700231Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
B915015700411ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
B915015700511zebris for ceramill USBzebris MEDICAL GmbHNFS2023-07-20
B915015700721PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
B915019602500Para-occlusal Attachment with Lip Archzebris MEDICAL GmbHNFS2023-07-13
B915019602510Para-occlusal Attachment with Lip Arch AGzebris MEDICAL GmbHNFS2023-07-13
B915019602550Para-occlusal Attachment with Support Surfacezebris MEDICAL GmbHNFS2023-07-13
B915019602600Para-occlusal Attachmentzebris MEDICAL GmbHNFS2023-07-13
B915019602800Occlusal Attachment UNzebris MEDICAL GmbHNFS2023-07-13
B915019603300Bite Fork Type SI / Fusion Bitezebris MEDICAL GmbHNFS2023-07-13
B915019603410Bite Fork PS1 zebris MEDICAL GmbHNFS2023-07-13
B915019603600Bite Fork UN zebris MEDICAL GmbHNFS2023-07-13
B915019604000Bite Fork Adapter / Fusion Bite Adapterzebris MEDICAL GmbHNFS2023-07-13
B915019604200Bite Fork Adapter UNzebris MEDICAL GmbHNFS2023-07-13