AccessGUDID - DEVICE: Sculpt I.Q. (D8076659101G1)

GUDID

Device Identifier (DI) Information

Brand Name: Sculpt I.Q.
Version or Model: 6659101G
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6659101G
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D8076659101G1
Issuing Agency: HIBCC
Commercial Distribution End Date: April 09, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: Sculpt I.Q. Laser, USA

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?
60340	Dental diode laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, infrared, therapeutic heating
GEX	Powered laser surgical instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 40877566-2f58-4ba2-85d0-570c817aa04b
Public Version Date: March 01, 2024
Public Version Number: 6
DI Record Publish Date: March 14, 2018