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 the device name listed in this FDA 510(k) record. The listed applicant is Sprig Oral Health Technologies, Inc.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) 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. The listed applicant is Sprig Oral Health Technologies, Inc.. The 510(k) number is K230797.

When did SmartMTA Capsule receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartMTA Capsule?

The FDA 510(k) record lists Sprig Oral Health Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartMTA Capsule?

The FDA product code for SmartMTA Capsule is KIF.

Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

Official Source

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