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FDA 510(k)

MINERAL TRIOXIDE AGGREGATE (MTA)

K-Number: K964174 · 1997-02-10

ApplicantTulsa Dental Products, Ltd.
Decision Date1997-02-10
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINERAL TRIOXIDE AGGREGATE (MTA) is the device name listed in this FDA 510(k) record. The listed applicant is Tulsa Dental Products, Ltd.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K964174. 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 MINERAL TRIOXIDE AGGREGATE (MTA)?

MINERAL TRIOXIDE AGGREGATE (MTA) is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Tulsa Dental Products, Ltd.. The 510(k) number is K964174.

When did MINERAL TRIOXIDE AGGREGATE (MTA) receive FDA 510(k) clearance?

MINERAL TRIOXIDE AGGREGATE (MTA) received FDA 510(k) clearance on 1997-02-10, under 510(k) number K964174.

Who is the listed applicant for MINERAL TRIOXIDE AGGREGATE (MTA)?

The FDA 510(k) record lists Tulsa Dental Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINERAL TRIOXIDE AGGREGATE (MTA)?

The FDA product code for MINERAL TRIOXIDE AGGREGATE (MTA) is KIF.

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Other records listing Tulsa Dental Products, Ltd. as applicant

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.

K970134THERMAPREP PLUS OVENK954790PROFILE NICKEL TITANIUM ROTARY INSTRUMENTSK922931THERMAPOST ENDODONTIC ROOT CANAL POSTK933582PROFILE SERIES 29 FILESK910224THERMAPREPK900986THERMAFIL ENDODONTIC OBTURATOR

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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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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