Cleared Traditional

GuttaSil (K190510) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190510 · Meta Biomed Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
89d
Days
Class 2
Risk

K190510 is an FDA 510(k) clearance for the GuttaSil. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Meta Biomed Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on May 29, 2019 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meta Biomed Co., Ltd. devices

Submission Details

510(k) Number K190510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2019
Decision Date May 29, 2019
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Withus Group, Inc.
April Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KIF Resin, Root Canal Filling

All 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K190510.
Dia-Proseal
K182009 · DiaDent Group International · Sep 2019
CeraSeal
K190503 · Meta Biomed Co., Ltd. · Jun 2019
Diapex Plus
K182625 · DiaDent Group International · Jun 2019
MTA2.3 MATERIALS
K181917 · NuSmile, Ltd. · Jan 2019
BIO-C TEMP
K180199 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2019
Sonendo Material A
K181922 · Sonendo, Inc. · Oct 2018