AccessGUDID - DEVICE: Palodent® Plus EZ Coat Sectional Matrix System (D0026596701)

GUDID

Device Identifier (DI) Information

Brand Name: Palodent® Plus EZ Coat Sectional Matrix System
Version or Model: 659670
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 659670
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026596701
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Palodent Plus EZ Coat Introductory Kit

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?
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	INSTRUMENTS, DENTAL HAND

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
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: 20x each of matrix bands (5 sizes), 25x each of wedges (3 sizes), 10x each of wedge guards (3 sizes), 2x Rings, 1x Forceps, 1x Tweezers

Device Record Status

Public Device Record Key: 952002b1-ebca-486b-8cac-aecca5e48e0c
Public Version Date: April 10, 2019
Public Version Number: 1
DI Record Publish Date: April 02, 2019