AccessGUDID - DEVICE: Para-occlusal Attachment (B915019602600)

GUDID

Device Identifier (DI) Information

Brand Name: Para-occlusal Attachment
Version or Model: 01960260
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: zebris MEDICAL GmbH

Primary DI Number: B915019602600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328971791 *Terms of Use

Device Description: The Para-occlusal Attachment is an accessory of the JMT+ facebow and used to attach the lower jaw sensor to the teeth.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35700	Facebow	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9fd024a-fac0-4dda-9fe3-c610d6a6595d
Public Version Date: July 21, 2023
Public Version Number: 1
DI Record Publish Date: July 13, 2023