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GuttaSil

by Meta Biomed Co., Ltd.

510(k) K190510

GuttaSil is a medical device (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Meta Biomed Co., Ltd., cleared under FDA 510(k) K190510 on 29 May 2019, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190510 Date29 May 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KIF
Device class
Class II
Regulation
21 CFR Part 872.3820
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Devices cleared under K190510

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K190510
UDI-DISize and differences
GuttaSil 9387
Meta Biomed Co., Ltd.
938708806387893875 —No longer on the market
GuttaSil Refill 9411
Meta Biomed Co., Ltd.
941108806387894117 —No longer on the market

Similar devices

Other devices filed under FDA product code KIF (Resin, Root Canal Filling).

Other devices from Meta Biomed Co., Ltd.

See all devices from Meta Biomed Co., Ltd. →