AccessGUDID - DEVICE: CERALOG® PL Bonding base crown, Ø 3.8 mm, GH 0.8 mm (07640161396548)

GUDID

Device Identifier (DI) Information

Brand Name: CERALOG® PL Bonding base crown, Ø 3.8 mm, GH 0.8 mm
Version or Model: HP2246.3808
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HP2246.3808
Company Name: CeramTec Schweiz GmbH

Primary DI Number: 07640161396548
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 483229493 *Terms of Use

Device Description: CERALOG® PL Bonding base crown, Ø 3.8 mm, GH 0.8 mm

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:	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?
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 [?]
K163043	000
K180184	000

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: 0ecfdf8f-a0e8-4b12-9a38-0bb3f1b4b85f
Public Version Date: February 25, 2025
Public Version Number: 3
DI Record Publish Date: April 29, 2024