Skip to content

BB Base 3D printing resin for denture base

by Enlighten Materials Co., Ltd. 510(k)

Active United States

510(k) K191591

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191591 Date18 Aug 2020ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EBI
Device Class
Class II
Regulation
21 CFR Part 872.3760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Enlighten Materials Co., Ltd.