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FDA 510(k)

PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER

K-Number: K943905 · 1995-02-27

ApplicantProfessional Positioners, Inc.
Decision Date1995-02-27
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER is the device name listed in this FDA 510(k) record. The listed applicant is Professional Positioners, Inc.. It received FDA 510(k) clearance on 1995-02-27 under 510(k) number K943905. 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 PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER?

PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Professional Positioners, Inc.. The 510(k) number is K943905.

When did PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER receive FDA 510(k) clearance?

PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER received FDA 510(k) clearance on 1995-02-27, under 510(k) number K943905.

Who is the listed applicant for PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER?

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

What is the FDA product code for PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER?

The FDA product code for PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER is EBI.

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Other records listing Professional Positioners, 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.

K932298PRO'S NEO-LASTICSK932761SOFT-WEAR HEADGEAR AND SAFETY MODULES

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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