AccessGUDID - DEVICE: SET ZZ BASE ST-SO-ICOTH RN 4.8 (Impression coping open tray hex and Sc (D800BSAQ0642)

GUDID

Device Identifier (DI) Information

Brand Name: SET ZZ BASE ST-SO-ICOTH RN 4.8 (Impression coping open tray hex and Sc
Version or Model: BSAQ0642
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRKONZAHN SRL

Primary DI Number: D800BSAQ0642
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 564251911 *Terms of Use

Device Description: Compatible with Straumann Tissue Level (Standard Plus Narrow Neck CrossFit _ SynOcta) implants Set consisting of: 1x Impression coping HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray

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?
46122	Dental implant suprastructure, temporary, preformed, reusable	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, implant, dental, endosseous

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 09733a5c-24dc-4116-b841-ba9ba6e1ace3
Public Version Date: October 05, 2021
Public Version Number: 1
DI Record Publish Date: September 27, 2021