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FDA 510(k)

SAVE-A-BAKE PORCELAIN POLISH

K-Number: K831483 · 1983-07-28

ApplicantDenpac Corp.
Decision Date1983-07-28
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAVE-A-BAKE PORCELAIN POLISH is the device name listed in this FDA 510(k) record. The listed applicant is Denpac Corp.. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831483. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAVE-A-BAKE PORCELAIN POLISH?

SAVE-A-BAKE PORCELAIN POLISH is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is Denpac Corp.. The 510(k) number is K831483.

When did SAVE-A-BAKE PORCELAIN POLISH receive FDA 510(k) clearance?

SAVE-A-BAKE PORCELAIN POLISH received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831483.

Who is the listed applicant for SAVE-A-BAKE PORCELAIN POLISH?

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

What is the FDA product code for SAVE-A-BAKE PORCELAIN POLISH?

The FDA product code for SAVE-A-BAKE PORCELAIN POLISH is EIH.

Related Clinical Trials

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Other records listing Denpac Corp. 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.

K873373SINTERLOYK831484COMPOSI-GLAZEK791160DENTALEEN

Related Devices (Code: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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