AccessGUDID - DEVICE: CERTAIN® PROVIDE® (00844868013884)

GUDID

Device Identifier (DI) Information

Brand Name: CERTAIN® PROVIDE®
Version or Model: PAK6255
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMET 3I, LLC

Primary DI Number: 00844868013884
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 186127825 *Terms of Use

Device Description: CERTAIN® PROVIDE® ABUTMENT PLACEMENT KIT 6.0MM(D) X 6.5MM(P) X 2MM(H) - 5.5MM POST

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
44881	Dental implant suprastructure kit	A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHA	ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter 6 mm
Device Size Text, specify: Post Height 5.5 mm
Height: 2 Millimeter

Device Record Status

Public Device Record Key: bae2cca4-1779-4ff6-96e7-5cd893899e65
Public Version Date: March 10, 2022
Public Version Number: 3
DI Record Publish Date: September 10, 2015