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FDA 510(k)

PERMASEAL AND DENTURE SEAL

K-Number: K884865 · 1989-01-30

ApplicantAmerican Mfg., Inc.
Decision Date1989-01-30
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMASEAL AND DENTURE SEAL is the device name listed in this FDA 510(k) record. The listed applicant is American Mfg., Inc.. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K884865. 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 PERMASEAL AND DENTURE SEAL?

PERMASEAL AND DENTURE SEAL is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is American Mfg., Inc.. The 510(k) number is K884865.

When did PERMASEAL AND DENTURE SEAL receive FDA 510(k) clearance?

PERMASEAL AND DENTURE SEAL received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884865.

Who is the listed applicant for PERMASEAL AND DENTURE SEAL?

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

What is the FDA product code for PERMASEAL AND DENTURE SEAL?

The FDA product code for PERMASEAL AND DENTURE SEAL is EBI.

Related Clinical Trials

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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Other records listing American Mfg., 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.

K884751DANSU PERMANENT CHAIR SOFT LINER

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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