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FDA 510(k)

ENDO-PREP

K-Number: K896663 · 1990-02-14

ApplicantPulpdent Corp.
Decision Date1990-02-14
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDO-PREP is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1990-02-14 under 510(k) number K896663. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-PREP?

ENDO-PREP is a medical device that received FDA 510(k) clearance on 1990-02-14. The listed applicant is Pulpdent Corp.. The 510(k) number is K896663.

When did ENDO-PREP receive FDA 510(k) clearance?

ENDO-PREP received FDA 510(k) clearance on 1990-02-14, under 510(k) number K896663.

Who is the listed applicant for ENDO-PREP?

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 ENDO-PREP?

The FDA product code for ENDO-PREP is EKM.

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: EKM)

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.

K073369EI DOWNPAK BARRIER SLEEVESHu-Friedy Mfg. Co., Inc.K070246DOWN PAKEndo Twinn B.V.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K042870ENDO TWINNEndo Twinn B.V.K023819FIBERFILL SGPPentron Clinical TechnologiesK971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.

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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