AccessGUDID - DEVICE: Form drill PROGRESSIVE-LINE (E219J507043111)

GUDID

Device Identifier (DI) Information

Brand Name: Form drill PROGRESSIVE-LINE
Version or Model: J5070.4311
Commercial Distribution Status: In Commercial Distribution
Catalog Number: J5070.4311
Company Name: ALTATEC GmbH

Primary DI Number: E219J507043111
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 322018193 *Terms of Use

Device Description: Form drill PROGRESSIVE-LINE, d 4.3 mm, L 11

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?
45714	Fixture/appliance dental drill bit, reusable	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJL	Bur, 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.3 Millimeter
Length: 11 Millimeter

Device Record Status

Public Device Record Key: ed6cdca0-bd3c-42b2-aa8d-50493d40dd86
Public Version Date: October 22, 2020
Public Version Number: 1
DI Record Publish Date: October 14, 2020