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FDA 510(k)

THERMAFIL ENDODONTIC OBTURATOR

K-Number: K881139 · 1988-04-07

ApplicantTulsa Dental Products, Ltd.
Decision Date1988-04-07
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THERMAFIL ENDODONTIC OBTURATOR 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 1988-04-07 under 510(k) number K881139. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMAFIL ENDODONTIC OBTURATOR?

THERMAFIL ENDODONTIC OBTURATOR is a medical device that received FDA 510(k) clearance on 1988-04-07. The listed applicant is Tulsa Dental Products, Ltd.. The 510(k) number is K881139.

When did THERMAFIL ENDODONTIC OBTURATOR receive FDA 510(k) clearance?

THERMAFIL ENDODONTIC OBTURATOR received FDA 510(k) clearance on 1988-04-07, under 510(k) number K881139.

Who is the listed applicant for THERMAFIL ENDODONTIC OBTURATOR?

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 THERMAFIL ENDODONTIC OBTURATOR?

The FDA product code for THERMAFIL ENDODONTIC OBTURATOR is EKM.

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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 POSTK933582PROFILE SERIES 29 FILESK910224THERMAPREP

View all 8 devices →

Related Devices (Code: EKM)

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.

K073369EI DOWNPAK BARRIER SLEEVESHu-Friedy Mfg. Co., Inc.K070246DOWN PAKEndo Twinn B.V.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K042870ENDO TWINNEndo Twinn B.V.K023819FIBERFILL SGPPentron Clinical TechnologiesK971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.

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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