AccessGUDID - DEVICE: BioTemps (D745701181MIL00941)

GUDID

Device Identifier (DI) Information

Brand Name: BioTemps
Version or Model: 70-1181-MIL0094
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-1181-MIL0094
Company Name: Prismatik Dentalcraft, Inc

Primary DI Number: D745701181MIL00941
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 022761689 *Terms of Use

Device Description: BioTemps NOW Milling Blocks; Bridge Block; B1 (5-pack)

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:	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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQC	Mouthguard, prescription
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201683	000

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: f88e239b-3208-4971-940d-5aa00383c177
Public Version Date: October 09, 2023
Public Version Number: 4
DI Record Publish Date: May 26, 2021