AccessGUDID - DEVICE: Power Dental USA (D9432820TO00)

GUDID

Device Identifier (DI) Information

Brand Name: Power Dental USA
Version or Model: 2820TO
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2820TO
Company Name: Power Dental U.S.A. Inc.

Primary DI Number: D9432820TO00
Issuing Agency: HIBCC
Commercial Distribution End Date: December 22, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 081305064 *Terms of Use

Device Description: BURNISHERS B28/29 TITANIUM OCTAGON HANDLE

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":	Yes
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?
38530	Dental spatula, reusable	A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.	Active	false
35696	Dental amalgam carrier	A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.	Active	false
64078	Manual dental burnisher, reusable	A hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKJ	BURNISHER, OPERATIVE

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 03e65c0b-5647-42bf-bd8b-b95f7e784bc0
Public Version Date: December 23, 2022
Public Version Number: 3
DI Record Publish Date: January 08, 2022