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FDA 510(k)

SmartMTA Capsule

K-Number: K230797 · 2023-03-24

ApplicantSprig Oral Health Technologies, Inc.
Decision Date2023-03-24
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SmartMTA Capsule is a medical device manufactured by Sprig Oral Health Technologies, Inc.. It received FDA 510(k) clearance on 2023-03-24 under approval number K230797. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartMTA Capsule?

SmartMTA Capsule is a medical device that received FDA 510(k) clearance on 2023-03-24. It is manufactured by Sprig Oral Health Technologies, Inc.. The 510(k) number is K230797.

When was SmartMTA Capsule approved by the FDA?

SmartMTA Capsule received FDA 510(k) clearance on 2023-03-24, under approval number K230797.

What company makes SmartMTA Capsule?

SmartMTA Capsule is manufactured by Sprig Oral Health Technologies, Inc..

What is the FDA product code for SmartMTA Capsule?

The FDA product code for SmartMTA Capsule is KIF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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