AccessGUDID - DEVICE: ProTech Plus Tooth Acrylic (D814RUCPOLB1)

GUDID

Device Identifier (DI) Information

Brand Name: ProTech Plus Tooth Acrylic
Version or Model: RUCPOLB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RUCPOLB
Company Name: PROTECH PROFESSIONAL PRODUCTS INC

Primary DI Number: D814RUCPOLB1
Issuing Agency: HIBCC
Commercial Distribution End Date: August 26, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 117374900 *Terms of Use

Device Description: 440 gram ProTech Plus Tooth Acrylic Shade Pink Opaque

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):	No
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?
34769	Denture reliner, elastic, short-term	A denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	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 [?]
K151646	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: 70d4e842-15c2-4453-8fa3-379ac0c0a14d
Public Version Date: May 20, 2019
Public Version Number: 5
DI Record Publish Date: August 26, 2016