AccessGUDID - DEVICE: Prisma® Gloss™ Composite Polishing Paste System (D0026240201)

GUDID

Device Identifier (DI) Information

Brand Name: Prisma® Gloss™ Composite Polishing Paste System
Version or Model: 624020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 624020
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026240201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Prisma® Gloss™ Polishing Cups Refill

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?
34771	Dental unfilled resin sealant/coating	A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.	Active	false
35170	Dental mandrel	A slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

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
Storage Environment Temperature: between 10 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 Polishing Cups, 1 Mandrel

Device Record Status

Public Device Record Key: 0647a67e-ff50-4611-9640-355c610a330f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016