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FDA 510(k)

PROFILE SERIES 29 FILES

K-Number: K933582 · 1993-10-20

ApplicantTulsa Dental Products, Ltd.
Decision Date1993-10-20
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROFILE SERIES 29 FILES 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 1993-10-20 under 510(k) number K933582. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFILE SERIES 29 FILES?

PROFILE SERIES 29 FILES is a medical device that received FDA 510(k) clearance on 1993-10-20. The listed applicant is Tulsa Dental Products, Ltd.. The 510(k) number is K933582.

When did PROFILE SERIES 29 FILES receive FDA 510(k) clearance?

PROFILE SERIES 29 FILES received FDA 510(k) clearance on 1993-10-20, under 510(k) number K933582.

Who is the listed applicant for PROFILE SERIES 29 FILES?

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 PROFILE SERIES 29 FILES?

The FDA product code for PROFILE SERIES 29 FILES is EKS.

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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 OVENK964174MINERAL TRIOXIDE AGGREGATE (MTA)K954790PROFILE NICKEL TITANIUM ROTARY INSTRUMENTSK922931THERMAPOST ENDODONTIC ROOT CANAL POSTK910224THERMAPREPK900986THERMAFIL ENDODONTIC OBTURATOR

View all 8 devices →

Related Devices (Code: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.

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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