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FDA 510(k)

JEDENTAL PSROFILL SELF-CURE COMPOSITE

K-Number: K933656 · 1993-11-17

ApplicantJedental Co., Inc.
Decision Date1993-11-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JEDENTAL PSROFILL SELF-CURE COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Jedental Co., Inc.. It received FDA 510(k) clearance on 1993-11-17 under 510(k) number K933656. 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 JEDENTAL PSROFILL SELF-CURE COMPOSITE?

JEDENTAL PSROFILL SELF-CURE COMPOSITE is a medical device that received FDA 510(k) clearance on 1993-11-17. The listed applicant is Jedental Co., Inc.. The 510(k) number is K933656.

When did JEDENTAL PSROFILL SELF-CURE COMPOSITE receive FDA 510(k) clearance?

JEDENTAL PSROFILL SELF-CURE COMPOSITE received FDA 510(k) clearance on 1993-11-17, under 510(k) number K933656.

Who is the listed applicant for JEDENTAL PSROFILL SELF-CURE COMPOSITE?

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

What is the FDA product code for JEDENTAL PSROFILL SELF-CURE COMPOSITE?

The FDA product code for JEDENTAL PSROFILL SELF-CURE COMPOSITE is EBF.

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Other records listing Jedental Co., 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.

K933612JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)K935718JEDENTAL VLC DENTAL CURING LIGHTK934073JEDENTAL GLASS IONOMER CEMENT AND LINERK935727P&FS PIT AND FISSURE SEALANTK933543ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)K933554JEDENTAL ZINC CEMENT IMPROVED

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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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