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FDA 510(k)

SCULPTURE PLUS NANO-HYBRID COMPOSITE

K-Number: K023742 · 2003-01-17

ApplicantPentron Laboratory Technologies
Decision Date2003-01-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCULPTURE PLUS NANO-HYBRID COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Laboratory Technologies. It received FDA 510(k) clearance on 2003-01-17 under 510(k) number K023742. 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 SCULPTURE PLUS NANO-HYBRID COMPOSITE?

SCULPTURE PLUS NANO-HYBRID COMPOSITE is a medical device that received FDA 510(k) clearance on 2003-01-17. The listed applicant is Pentron Laboratory Technologies. The 510(k) number is K023742.

When did SCULPTURE PLUS NANO-HYBRID COMPOSITE receive FDA 510(k) clearance?

SCULPTURE PLUS NANO-HYBRID COMPOSITE received FDA 510(k) clearance on 2003-01-17, under 510(k) number K023742.

Who is the listed applicant for SCULPTURE PLUS NANO-HYBRID COMPOSITE?

The FDA 510(k) record lists Pentron Laboratory Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCULPTURE PLUS NANO-HYBRID COMPOSITE?

The FDA product code for SCULPTURE PLUS NANO-HYBRID COMPOSITE is EBF.

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Other records listing Pentron Laboratory Technologies 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.

K023499GOLD CORE PLUSK023502JEWEL CAST PLUSK023501GOLD CORE 35K020555SONATA MICRO HYBRID COMPOSITE

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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