AccessGUDID - DEVICE: SF1LM KO Air Scaler (J021100355111)

GUDID

Device Identifier (DI) Information

Brand Name: SF1LM KO Air Scaler
Version or Model: 10035511
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: W & H Dentalwerk Bürmoos GmbH

Primary DI Number: J021100355111
Issuing Agency: HIBCC
Commercial Distribution End Date: August 07, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 300238441 *Terms of Use

Device Description: Brasseler Air Scaler

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?
44911	Pneumatic dental scaling/debridement system	An assembly of devices designed to use compressed air to generate a vibrating action at its point of patient contact to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. It typically consists of a handpiece which converts pneumatic energy into sonic vibrational energy (e.g., at a frequency of 6 kHz); appropriate connection tubing; and a self-locking, removable tip(s); tip selection typically affects the intended application (endodontic vs periodontal).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, Air-Powered, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 5d346ada-a11f-4128-a643-5925ed7dc175
Public Version Date: August 08, 2024
Public Version Number: 2
DI Record Publish Date: August 31, 2018