AccessGUDID - DEVICE: 2CONnect® (ENTT2CON9S3D14001)

GUDID

Device Identifier (DI) Information

Brand Name: 2CONnect®
Version or Model: 2CON 9.S3D1.400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2CON 9.S3D1.400
Company Name: NT-Trading GmbH & Co. KG

Primary DI Number: ENTT2CON9S3D14001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312800478 *Terms of Use

Device Description: 2-CONnect® Scanbody 3D-Guide®

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?
61641	Dental implant abutment analog, intraoral-scanning, single-use	An intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.	Active	false

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 KS60 (M1.4) coping screw

Device Record Status

Public Device Record Key: b03520ad-6a78-4d97-b314-a027dcf7442e
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: July 20, 2023