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FDA 510(k)

PASTES, RESTORATIVE & TINTED, DEBTAL

K-Number: K771119 · 1977-07-15

ApplicantEspe Dental Products
Decision Date1977-07-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PASTES, RESTORATIVE & TINTED, DEBTAL is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental Products. It received FDA 510(k) clearance on 1977-07-15 under 510(k) number K771119. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASTES, RESTORATIVE & TINTED, DEBTAL?

PASTES, RESTORATIVE & TINTED, DEBTAL is a medical device that received FDA 510(k) clearance on 1977-07-15. The listed applicant is Espe Dental Products. The 510(k) number is K771119.

When did PASTES, RESTORATIVE & TINTED, DEBTAL receive FDA 510(k) clearance?

PASTES, RESTORATIVE & TINTED, DEBTAL received FDA 510(k) clearance on 1977-07-15, under 510(k) number K771119.

Who is the listed applicant for PASTES, RESTORATIVE & TINTED, DEBTAL?

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

What is the FDA product code for PASTES, RESTORATIVE & TINTED, DEBTAL?

The FDA product code for PASTES, RESTORATIVE & TINTED, DEBTAL is EBF.

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Other records listing Espe Dental Products 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.

K810950VISIO-SEALK802819KETAC-CEM IN REF. TO K802048K802049NIMETIC-DISPERSK800031PERMADYNE POLYETHER RUBBER IMPRESSIONK771889UNIOLITEK771901CAPMIX

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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