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FDA 510(k)

DENTURE RELINE MATERIAL

K-Number: K780786 · 1978-06-14

ApplicantDentsply Intl.
Decision Date1978-06-14
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTURE RELINE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1978-06-14 under 510(k) number K780786. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTURE RELINE MATERIAL?

DENTURE RELINE MATERIAL is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is Dentsply Intl.. The 510(k) number is K780786.

When did DENTURE RELINE MATERIAL receive FDA 510(k) clearance?

DENTURE RELINE MATERIAL received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780786.

Who is the listed applicant for DENTURE RELINE MATERIAL?

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

What is the FDA product code for DENTURE RELINE MATERIAL?

The FDA product code for DENTURE RELINE MATERIAL is EBI.

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Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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