AccessGUDID - DEVICE: SET ZZ BASE ID-ODA-WSM (D800ZBCD4431)

GUDID

Device Identifier (DI) Information

Brand Name: SET ZZ BASE ID-ODA-WSM
Version or Model: ZBCD4431
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRKONZAHN SRL

Primary DI Number: D800ZBCD4431
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 564251911 *Terms of Use

Device Description: SET ZZ BASE ID-ODA-WSM (White Scanmarker and screw). The ZZ BASE WSM (WHITE SCANMARKER) allows the user to record the implant position and inclination in the patient’s mouth or on the model.

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:	Yes
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?
61641	Dental implant abutment analog, scanning	A non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.	Active	false

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: 720baf01-f702-4ace-959a-8354f9a2a83d
Public Version Date: October 02, 2020
Public Version Number: 1
DI Record Publish Date: September 24, 2020