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FDA 510(k)

CRYSTALLESSENCE

K-Number: K954988 · 1996-03-08

ApplicantConfi-Dental Products Co.
Decision Date1996-03-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTALLESSENCE is the device name listed in this FDA 510(k) record. The listed applicant is Confi-Dental Products Co.. It received FDA 510(k) clearance on 1996-03-08 under 510(k) number K954988. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYSTALLESSENCE?

CRYSTALLESSENCE is a medical device that received FDA 510(k) clearance on 1996-03-08. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K954988.

When did CRYSTALLESSENCE receive FDA 510(k) clearance?

CRYSTALLESSENCE received FDA 510(k) clearance on 1996-03-08, under 510(k) number K954988.

Who is the listed applicant for CRYSTALLESSENCE?

The FDA 510(k) record lists Confi-Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYSTALLESSENCE?

The FDA product code for CRYSTALLESSENCE is EBF.

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Other records listing Confi-Dental Products 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.

K030807CARIES INDICATORK030743ETCHANT 40%K955328CONFI-BONDK955329RESILIENCE M5 PROTECTION PLUSK952930DENTRAY II PLUS TRAY ADHESIVEK946307CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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