AccessGUDID - DEVICE: DENTSPLY® Repair Material (D0016800280)

GUDID

Device Identifier (DI) Information

Brand Name: DENTSPLY® Repair Material
Version or Model: Labpak Kit Light Fibered
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 680028
Company Name: Dentsply International Inc.

Primary DI Number: D0016800280
Issuing Agency: HIBCC
Commercial Distribution End Date: June 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 606173334 *Terms of Use

Device Description: Contains 454 grams of DENTSPLY Repair Material Light Fibered, one (1) 21 gram bottle of DENTSPLY Repair Material Pink Free-Flow, and two (2) 175 milliliter bottles of DENTSPLY Repair Material Liquid

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 454 Gram
Weight: 21 Gram
Total Volume: 175 Milliliter

Device Record Status

Public Device Record Key: 472673a2-c958-4ce6-9862-fdc6343841b7
Public Version Date: June 03, 2024
Public Version Number: 6
DI Record Publish Date: January 31, 2017