AccessGUDID - DEVICE: Etchmaster (D798EMTLS1)

GUDID

Device Identifier (DI) Information

Brand Name: Etchmaster
Version or Model: EMTLS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EMTLS
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798EMTLS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: The Etchmaster system is intended for use for polishing, roughening, and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is a 25 pack of the Etchmaster Small Lingual tips.

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?
45403	Dental abrasive air jet system	An assembly of devices that together comprise a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth or teeth. It typically consists of a control unit, a dedicated handpiece and a foot switch that enables the dentist to control the abrasion process. It has a wide variety of applications such as, the removal of plaque and stains, cleaning fissures (above and below the gingival), the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue and the cleaning of implants prior to loading.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOJ	Airbrush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030292	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: 30f0e917-0ce6-419c-ae51-8fddec6add78
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 04, 2016