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FDA 510(k)

PROFILL LC COMPOSITE

K-Number: K931880 · 1993-07-08

ApplicantJedental Co., Inc.
Decision Date1993-07-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROFILL LC 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 1993-07-08 under 510(k) number K931880. 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 PROFILL LC COMPOSITE?

PROFILL LC COMPOSITE is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Jedental Co., Inc.. The 510(k) number is K931880.

When did PROFILL LC COMPOSITE receive FDA 510(k) clearance?

PROFILL LC COMPOSITE received FDA 510(k) clearance on 1993-07-08, under 510(k) number K931880.

Who is the listed applicant for PROFILL LC 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 PROFILL LC COMPOSITE?

The FDA product code for PROFILL LC 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 SEALANTK933656JEDENTAL PSROFILL SELF-CURE COMPOSITEK933554JEDENTAL ZINC CEMENT IMPROVED

View all 8 devices →

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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