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Bone Level Tapered Implant, Φ4.1mm, L18mm, No-mount 318010G

by BIO CONCEPT Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06947600321811 UDI-DI Date5 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bone Level Tapered Implant,Φ4.1mm,L18mm,No-mount
Generic Name
Dental implant system
Model / Reference
318010G
Primary DI / UDI-DI
06947600321811
510(k) Number
FDA Product Code
DZE
GMDN Term
Dental implant system
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K212364)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No