AccessGUDID - DEVICE: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS (07630031713612)

GUDID

Device Identifier (DI) Information

Brand Name: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS
Version or Model: Final Abutments
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 027.4310
Company Name: Institut Straumann AG

Primary DI Number: 07630031713612
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: NC Cementable All-In-One Set, for crown, D 5mm, AH 5.5mm, GH 1mm

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 [?]
K080286	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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter
Device Size Text, specify: AH 5.5mm, GH 1mm

Device Record Status

Public Device Record Key: 7841ac3b-8c5b-4a26-82ed-15fe99f85c31
Public Version Date: September 02, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2015