AccessGUDID - DEVICE: PURE Ceramic Implants (07630031714244)

GUDID

Device Identifier (DI) Information

Brand Name: PURE Ceramic Implants
Version or Model: Protective caps
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 031.321
Company Name: Institut Straumann AG

Primary DI Number: 07630031714244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: ND Protective Cap, AH 5.5 mm, PEEK

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?
44880	Dental implant suprastructure, temporary, preformed, single-use	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151328	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
Device Size Text, specify: AH 5.5mm
Outer Diameter: 3.3 Millimeter

Device Record Status

Public Device Record Key: 1e203b81-34b6-4bf0-b0d7-6e4d1380d4ee
Public Version Date: September 02, 2019
Public Version Number: 5
DI Record Publish Date: January 14, 2016