AccessGUDID - DEVICE: 2-CONnect® (ENTTTHO2CON80450A3M1)

GUDID

Device Identifier (DI) Information

Brand Name: 2-CONnect®
Version or Model: THO-2CON 80450A3M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: THO-2CON 80450A3M
Company Name: NT-Trading GmbH & Co. KG

Primary DI Number: ENTTTHO2CON80450A3M1
Issuing Agency: HIBCC
Commercial Distribution End Date: April 19, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 312800478 *Terms of Use

Device Description: No description.

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):	No
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?
61647	Dental prosthesis/implant abutment screw	A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	Active	true
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111935	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2-CONnect®-Abutment Ø 4,5 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Thommen Medical® / SPI® Implant

Device Record Status

Public Device Record Key: 7a47324c-957c-4c78-8cd6-e5fa8f354b96
Public Version Date: May 10, 2023
Public Version Number: 4
DI Record Publish Date: August 23, 2019