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FDA 510(k)

MODERN MATERIALS ORTHODONTIC RESIN

K-Number: K913699 · 1991-10-09

ApplicantHeraeus Kulzer, Inc.
Decision Date1991-10-09
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODERN MATERIALS ORTHODONTIC RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1991-10-09 under 510(k) number K913699. 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 MODERN MATERIALS ORTHODONTIC RESIN?

MODERN MATERIALS ORTHODONTIC RESIN is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K913699.

When did MODERN MATERIALS ORTHODONTIC RESIN receive FDA 510(k) clearance?

MODERN MATERIALS ORTHODONTIC RESIN received FDA 510(k) clearance on 1991-10-09, under 510(k) number K913699.

Who is the listed applicant for MODERN MATERIALS ORTHODONTIC RESIN?

The FDA 510(k) record lists Heraeus Kulzer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODERN MATERIALS ORTHODONTIC RESIN?

The FDA product code for MODERN MATERIALS ORTHODONTIC RESIN is EBI.

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Other records listing Heraeus Kulzer, Inc. 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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.

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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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