AccessGUDID - DEVICE: FluoroPost™ Endodontic Fiber Post (D00261I0431)

GUDID

Device Identifier (DI) Information

Brand Name: FluoroPost™ Endodontic Fiber Post
Version or Model: 61i043
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61i043
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00261I0431
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: FluoroPost™ Precision Drill Refill - Size 3 (blue)

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":	Yes
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?
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
DZA	DRILL, DENTAL, INTRAORAL

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
Storage Environment Temperature: between 10 and 24 Degrees Celsius
Special Storage Condition, Specify: Allow material to reach room temperature prior to use.
Special Storage Condition, Specify: Keep out of direct sunlight and protect from moisture.
Special Storage Condition, Specify: Store at temperatures between 10°C/50°F and 24°C/75°F.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3 Drills (Size #3 Blue)

Device Record Status

Public Device Record Key: 79899561-b41f-4f0c-86c5-b95378c3a9bd
Public Version Date: September 01, 2022
Public Version Number: 1
DI Record Publish Date: August 24, 2022