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FDA 510(k)

PULPDENT DENTAL BOND ENHANCER 2-B

K-Number: K931710 · 1993-08-24

ApplicantPulpdent Corp.
Decision Date1993-08-24
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT DENTAL BOND ENHANCER 2-B is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1993-08-24 under 510(k) number K931710. 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 DENTAL BOND ENHANCER 2-B?

PULPDENT DENTAL BOND ENHANCER 2-B is a medical device that received FDA 510(k) clearance on 1993-08-24. The listed applicant is Pulpdent Corp.. The 510(k) number is K931710.

When did PULPDENT DENTAL BOND ENHANCER 2-B receive FDA 510(k) clearance?

PULPDENT DENTAL BOND ENHANCER 2-B received FDA 510(k) clearance on 1993-08-24, under 510(k) number K931710.

Who is the listed applicant for PULPDENT DENTAL BOND ENHANCER 2-B?

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 DENTAL BOND ENHANCER 2-B?

The FDA product code for PULPDENT DENTAL BOND ENHANCER 2-B 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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