AccessGUDID - DEVICE: Primescan 2 Multiuse Sleeve (E27668053650)

GUDID

Device Identifier (DI) Information

Brand Name: Primescan 2 Multiuse Sleeve
Version or Model: 6805365
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6805365
Company Name: SIRONA Dental Systems GmbH

Primary DI Number: E27668053650
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 340306351 *Terms of Use

Device Description: Primescan 2 Multiuse Sleeve

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?
63669	Intraoral optical scanning system	An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOF	System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 2a8d5392-f723-491c-b155-5e84b7a592f7
Public Version Date: May 14, 2025
Public Version Number: 1
DI Record Publish Date: May 06, 2025