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FDA 510(k)

PULPDENT UNFILLED DUAL CURE BONDING RESIN

K-Number: K930989 · 1993-04-20

ApplicantPulpdent Corp.
Decision Date1993-04-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT UNFILLED DUAL CURE BONDING RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K930989. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT UNFILLED DUAL CURE BONDING RESIN?

PULPDENT UNFILLED DUAL CURE BONDING RESIN is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Pulpdent Corp.. The 510(k) number is K930989.

When did PULPDENT UNFILLED DUAL CURE BONDING RESIN receive FDA 510(k) clearance?

PULPDENT UNFILLED DUAL CURE BONDING RESIN received FDA 510(k) clearance on 1993-04-20, under 510(k) number K930989.

Who is the listed applicant for PULPDENT UNFILLED DUAL CURE BONDING RESIN?

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 UNFILLED DUAL CURE BONDING RESIN?

The FDA product code for PULPDENT UNFILLED DUAL CURE BONDING RESIN is KLE.

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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

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Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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