AccessGUDID - DEVICE: RONDOflex powder 27m (1000g) (EKAV100059570)

GUDID

Device Identifier (DI) Information

Brand Name: RONDOflex powder 27m (1000g)
Version or Model: 1.000.5957
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA
Company Name: KaVo Dental GmbH

Primary DI Number: EKAV100059570
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333710619 *Terms of Use

Device Description: This is a medical device.

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:	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?
45407	Dental abrasive powder	A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices. It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a 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. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOJ	AIRBRUSH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042872	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
Handling Environment Temperature: between -50 and 80 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e84032c9-b7ab-4d00-bc8e-2c9c3bf37426
Public Version Date: November 08, 2021
Public Version Number: 5
DI Record Publish Date: September 26, 2016