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FDA 510(k)

CRYSTAR(TM) VINTAGE PORCELAIN

K-Number: K884214 · 1988-12-08

ApplicantShofu Dental Corp.
Decision Date1988-12-08
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTAR(TM) VINTAGE PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1988-12-08 under 510(k) number K884214. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYSTAR(TM) VINTAGE PORCELAIN?

CRYSTAR(TM) VINTAGE PORCELAIN is a medical device that received FDA 510(k) clearance on 1988-12-08. The listed applicant is Shofu Dental Corp.. The 510(k) number is K884214.

When did CRYSTAR(TM) VINTAGE PORCELAIN receive FDA 510(k) clearance?

CRYSTAR(TM) VINTAGE PORCELAIN received FDA 510(k) clearance on 1988-12-08, under 510(k) number K884214.

Who is the listed applicant for CRYSTAR(TM) VINTAGE PORCELAIN?

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

What is the FDA product code for CRYSTAR(TM) VINTAGE PORCELAIN?

The FDA product code for CRYSTAR(TM) VINTAGE PORCELAIN is ELL.

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Other records listing Shofu Dental 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.

K111855HY-BOND RESIGLASSK110235BEAUTIBOND MULTIK110252BEAUTIBOND MULTI PR PLUSK101621LITE ARTK101603BEAUTIFIL FLOW PLUSK093559VINTAGE MP

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Related Devices (Code: ELL)

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.

K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.K203072Franz Zirconia Dental CrownFranz Biotech, Inc.K162043NobelProcera HT ML FCZ BridgeNobel Biocare ABK153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare ABK071182PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013Nobel Biocare ABK060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.Lifecore Biomedical, 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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