AccessGUDID - DEVICE: SCOTT'S 20K CONTRA ANGLE (D77813514100)

GUDID

Device Identifier (DI) Information

Brand Name: SCOTT'S 20K CONTRA ANGLE
Version or Model: 135-1410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 135-1410
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77813514100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: CONTRA ANGLE (1/pack) Speed: Economical (20,000 RPM, Bearing: Sleeve; For more information: https://www.scottsdental.com/doriot-u-type-contra-angles.html

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?
63511	Dental power tool converter attachment, rotary	A dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a rotational mechanical motion to achieve a specific function [e.g., drilling] during dental or orthodontic procedures. It is not an endpiece; an appropriate interchangeable endpiece (e.g., drill bit, dental bur) is intended to be fixed to the working end of this device. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EGS	Handpiece, contra- and right-angle attachment, dental

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e44361a-fd52-40c8-b6e2-0c8b6b54319c
Public Version Date: March 08, 2021
Public Version Number: 1
DI Record Publish Date: February 27, 2021