Cleared Traditional

K230797 - SmartMTA Capsule (FDA 510(k) Clearance)

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

K230797 · Sprig Oral Health Technologies, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
2d
Days
Class 2
Risk

K230797 is an FDA 510(k) clearance for the SmartMTA Capsule. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Sprig Oral Health Technologies, Inc. (Loomis, US). The FDA issued a Cleared decision on March 24, 2023 after a review of 2 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 Sprig Oral Health Technologies, Inc. devices

Submission Details

510(k) Number K230797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2023
Decision Date March 24, 2023
Days to Decision 2 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 127d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 142
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K230797.
Any-Paste
K253167 · Mediclus Co., Ltd. · Jan 2026
ZenSeal Pro
K252890 · Kerr Corporation · Jan 2026
Root canal repair materials (nRoot BP)
K251465 · Enpuno Biotechnology Co., Ltd. · Sep 2025
Well-Root PT
K252285 · Vericom Co., Ltd. · Sep 2025
One-Fil Putty Injectable
K251884 · Mediclus Co., Ltd. · Aug 2025
MTA vpt
K251390 · Voco GmbH · Jul 2025