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FDA 510(k)

CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST

K-Number: K894644 · 1989-10-20

ApplicantJeneric/Pentron, Inc.
Decision Date1989-10-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1989-10-20 under 510(k) number K894644. 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 CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST?

CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST is a medical device that received FDA 510(k) clearance on 1989-10-20. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K894644.

When did CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST receive FDA 510(k) clearance?

CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST received FDA 510(k) clearance on 1989-10-20, under 510(k) number K894644.

Who is the listed applicant for CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST?

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

What is the FDA product code for CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST?

The FDA product code for CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST is EBF.

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Other records listing Jeneric/Pentron, 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.

K020499BOND-3 ADHESIVEK013543BOND-1 C & BK013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)K012231AVANTE MICRO CRYSTAL SYSTEMK011748FIRST FILL R.C.S.K010957QUELL DESENSITIZER

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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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