AccessGUDID - DEVICE: DENTSPLY TruByte® Repair Material (D0026800111)

GUDID

Device Identifier (DI) Information

Brand Name: DENTSPLY TruByte® Repair Material
Version or Model: 680011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 680011
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026800111
Issuing Agency: HIBCC
Commercial Distribution End Date: June 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: DENTSPLY TruByte® Repair Material Labpak Kits - Pink Fibered

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:	Yes
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?
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING

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
Special Storage Condition, Specify: Keep away from moisture and direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Weight: 21 Gram
Device Size Text, specify: 1 Bottle Powder (454 g), 1 bottle Pink Free-Flow powder (21 g), 1 Powder Dispenser, 2 Bottles Liquid (175 ml)
Weight: 454 Gram

Device Record Status

Public Device Record Key: 89223d12-a542-473b-a071-977741ee9b87
Public Version Date: June 03, 2024
Public Version Number: 5
DI Record Publish Date: September 21, 2016