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FDA 510(k)

PULPDENT CERVICAL RESTORATIVE

K-Number: K945113 · 1994-12-14

ApplicantPulpdent Corp.
Decision Date1994-12-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT CERVICAL RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K945113. 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 PULPDENT CERVICAL RESTORATIVE?

PULPDENT CERVICAL RESTORATIVE is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Pulpdent Corp.. The 510(k) number is K945113.

When did PULPDENT CERVICAL RESTORATIVE receive FDA 510(k) clearance?

PULPDENT CERVICAL RESTORATIVE received FDA 510(k) clearance on 1994-12-14, under 510(k) number K945113.

Who is the listed applicant for PULPDENT CERVICAL RESTORATIVE?

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

What is the FDA product code for PULPDENT CERVICAL RESTORATIVE?

The FDA product code for PULPDENT CERVICAL RESTORATIVE is EBF.

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Other records listing Pulpdent Corp. 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.

K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTK014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEK020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMK014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEK013411PULPDENT CAVITY PREPARATION IVK994180PULPDENT CAVITY PREPARATION III

View all 78 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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