AccessGUDID - DEVICE: DURAGUARD (D746DGSC060X25S1)

GUDID

Device Identifier (DI) Information

Brand Name: DURAGUARD
Version or Model: DGSC060X25S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DGSC060X25S
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D746DGSC060X25S1
Issuing Agency: HIBCC
Commercial Distribution End Date: February 18, 2021
Device Count: 25
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: DURAGUARD CLEAR .060 (1.5mm) SQUARE 25PK

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":	Yes
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?
47974	Dental implant x-ray template	A non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQC	Mouthguard, prescription

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: 0a60767a-9d0f-4417-9c8f-4197cc9cd873
Public Version Date: January 26, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016