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FDA 510(k)

BIOLASTIC SUPER ELASTIC ARCHES

K-Number: K902050 · 1990-08-03

ApplicantRmo, Inc.
Decision Date1990-08-03
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOLASTIC SUPER ELASTIC ARCHES is the device name listed in this FDA 510(k) record. The listed applicant is Rmo, Inc.. It received FDA 510(k) clearance on 1990-08-03 under 510(k) number K902050. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLASTIC SUPER ELASTIC ARCHES?

BIOLASTIC SUPER ELASTIC ARCHES is a medical device that received FDA 510(k) clearance on 1990-08-03. The listed applicant is Rmo, Inc.. The 510(k) number is K902050.

When did BIOLASTIC SUPER ELASTIC ARCHES receive FDA 510(k) clearance?

BIOLASTIC SUPER ELASTIC ARCHES received FDA 510(k) clearance on 1990-08-03, under 510(k) number K902050.

Who is the listed applicant for BIOLASTIC SUPER ELASTIC ARCHES?

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

What is the FDA product code for BIOLASTIC SUPER ELASTIC ARCHES?

The FDA product code for BIOLASTIC SUPER ELASTIC ARCHES is EJF.

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Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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