AccessGUDID - DEVICE: OptraSculpt (07615208294859)

GUDID

Device Identifier (DI) Information

Brand Name: OptraSculpt
Version or Model: 683066AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 683066AN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: 07615208294859
Issuing Agency: GS1
Commercial Distribution End Date: January 29, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use
Previous DI: DVIV683066AN1

Device Description: OptraSculpt & OptraSculpt Pad System Kit

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?
41861	Dental restoration carver, resin	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXR	APPLICATOR, RESIN

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: b5c328d5-62b8-480f-8ab1-dffb515d7857
Public Version Date: January 30, 2025
Public Version Number: 2
DI Record Publish Date: August 07, 2023