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LS Block LBC14B2

by Genoss

LS Block LBC14B2 is a Class II device made by Genoss, cleared under FDA 510(k) K160144 on 21 Jul 2016 and listed in FDA GUDID since 10 Jul 2018 (UDI-DI 08809552964585), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K160144

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809552964585 UDI-DI Date10 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160144 Date21 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160144 decided 21 Jul 2016 Active
  • FDA GUDID UDI-DI 08809552964585 listed 10 Jul 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160144
  2. Listed FDA GUDID 08809552964585

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LS Block
Generic name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
LBC14B2
Primary DI / UDI-DI
08809552964585
510(k) Number
FDA product code
EIH
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class II
Regulation number
872.6660
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
Size
Length — 15 Millimeter

Similar devices in this category

Other devices filed under Dental appliance fabrication material, ceramic.

Other devices from Genoss

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (10, all answered No)