AccessGUDID - DEVICE: 2CONnect® (ENTT2CONTR0002181)

GUDID

Device Identifier (DI) Information

Brand Name: 2CONnect®
Version or Model: 2CON TR-00021.8
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2CON TR-00021.8
Company Name: NT-Trading GmbH & Co. KG

Primary DI Number: ENTT2CONTR0002181
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312800478 *Terms of Use

Device Description: 2-CONnect®-Implant pick-up

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
NDP	Accessories, implant, dental, endosseous

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: for 2CONnect® Abutment with KS61 (M1.8) coping screw

Device Record Status

Public Device Record Key: 29f3d513-2526-4ccd-b4aa-b7cb2dc11d85
Public Version Date: July 28, 2023
Public Version Number: 1
DI Record Publish Date: July 20, 2023