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FDA 510(k)

MICRO JOIN, CROWN & BRIDGE ADHESIVE

K-Number: K823935 · 1983-02-07

ApplicantSci-Pharm, Inc.
Decision Date1983-02-07
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICRO JOIN, CROWN & BRIDGE ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Sci-Pharm, Inc.. It received FDA 510(k) clearance on 1983-02-07 under 510(k) number K823935. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO JOIN, CROWN & BRIDGE ADHESIVE?

MICRO JOIN, CROWN & BRIDGE ADHESIVE is a medical device that received FDA 510(k) clearance on 1983-02-07. The listed applicant is Sci-Pharm, Inc.. The 510(k) number is K823935.

When did MICRO JOIN, CROWN & BRIDGE ADHESIVE receive FDA 510(k) clearance?

MICRO JOIN, CROWN & BRIDGE ADHESIVE received FDA 510(k) clearance on 1983-02-07, under 510(k) number K823935.

Who is the listed applicant for MICRO JOIN, CROWN & BRIDGE ADHESIVE?

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

What is the FDA product code for MICRO JOIN, CROWN & BRIDGE ADHESIVE?

The FDA product code for MICRO JOIN, CROWN & BRIDGE ADHESIVE is EMA.

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Other records listing Sci-Pharm, 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.

K820092SECURE-ON-TOUCHK813090COMPOSITE DENTAL RESTORATIVE MATERIALK813091FISSURE SEALER & BONDING AGENTK812545BEAUFILLK812550BEAUCAVK812549BEAUSEAL

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Related Devices (Code: EMA)

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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