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FDA 510(k)

MONARCH II BLEACHING INSTRUMENT

K-Number: K854692 · 1986-05-12

ApplicantAlmore Intl., Inc.
Decision Date1986-05-12
Product CodeEEG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MONARCH II BLEACHING INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Almore Intl., Inc.. It received FDA 510(k) clearance on 1986-05-12 under 510(k) number K854692. The device is classified under product code EEG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH II BLEACHING INSTRUMENT?

MONARCH II BLEACHING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1986-05-12. The listed applicant is Almore Intl., Inc.. The 510(k) number is K854692.

When did MONARCH II BLEACHING INSTRUMENT receive FDA 510(k) clearance?

MONARCH II BLEACHING INSTRUMENT received FDA 510(k) clearance on 1986-05-12, under 510(k) number K854692.

Who is the listed applicant for MONARCH II BLEACHING INSTRUMENT?

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

What is the FDA product code for MONARCH II BLEACHING INSTRUMENT?

The FDA product code for MONARCH II BLEACHING INSTRUMENT is EEG.

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Other records listing Almore Intl., 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.

K862851ALMORE FACE MASKK854696OP II VISIBLE LIGHT CURING SYSTEMK854690DIAMONDS BURS-COMPOSIT FINISHINGK854691DIAMOND BURS-HANDPIECEK854700EZ-ON TUBING CONDITIONER (LUBRICANT)K854701RETRACT-A-CORD

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Related Devices (Code: EEG)

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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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