AccessGUDID - DEVICE: FluoroPost™ Endodontic Fiber Post (D00261I0221)

GUDID

Device Identifier (DI) Information

Brand Name: FluoroPost™ Endodontic Fiber Post
Version or Model: 61i021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61i022
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00261I0221
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: FluoroPost™ Peaso Reamer Refill - Size 2 (for post #3 and #4)

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?
37871	Crown surgical drill bit, reusable	A shaft of metal with a hollow centre designed for overdrilling a surgical screw or screw shaft to expose it for its removal, with another instrument, when the screw head has become defective or detached. The device is commonly called a "hollow mill" or "crown drill", but may also be referred to as a "hollow reamer", and is designed as a cylindrical hollow shell with a thin wall that has saw teeth at the cutting edge. It is inserted into a surgical power tool for rotation. This device may also be used to obtain core bone biopsies. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKP	REAMER, PULP CANAL, ENDODONTIC

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: Store at temperatures between 10°C/50°F and 24°C/75°F.
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.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3 FluoroPost™ Precision Drills - Size 2

Device Record Status

Public Device Record Key: f7f86d44-edbd-4090-8b3c-a2bd29d4aedd
Public Version Date: September 01, 2022
Public Version Number: 1
DI Record Publish Date: August 24, 2022