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2-CONnect® BIO-2CON 8045002M

by NT-Trading GmbH & Co. KG

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberENTTBIO2CON8045002M1 UDI-DI Date23 Aug 2019ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
2-CONnect®
Generic Name
Dental prosthesis/implant abutment screw
Model / Ref / Catalog
BIO-2CON 8045002M
Primary DI / UDI-DI
ENTTBIO2CON8045002M1
510(k) Number
FDA Product Code
NHA
GMDN Term
Dental prosthesis/implant abutment screw
Device Class
Class II
Regulation Number
872.3630
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Dry Heat Sterilization
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K111935)

Other devices from NT-Trading GmbH & Co. KG

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Properties

  • Single Use
  • Implantable
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No