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FDA 510(k)

COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS

K-Number: K900799 · 1990-05-15

ApplicantComfort Acrylics Co.
Decision Date1990-05-15
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Acrylics Co.. It received FDA 510(k) clearance on 1990-05-15 under 510(k) number K900799. 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 COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS?

COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Comfort Acrylics Co.. The 510(k) number is K900799.

When did COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS receive FDA 510(k) clearance?

COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS received FDA 510(k) clearance on 1990-05-15, under 510(k) number K900799.

Who is the listed applicant for COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS?

The FDA 510(k) record lists Comfort Acrylics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS?

The FDA product code for COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS 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 Comfort Acrylics Co. 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.

K910795COMFOR-DENT DENTURE 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

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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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