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FDA 510(k)

MODIFICATION TO PROMPT L-POP

K-Number: K001494 · 2000-07-07

ApplicantEspe Dental AG
Decision Date2000-07-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PROMPT L-POP is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental AG. It received FDA 510(k) clearance on 2000-07-07 under 510(k) number K001494. 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 MODIFICATION TO PROMPT L-POP?

MODIFICATION TO PROMPT L-POP is a medical device that received FDA 510(k) clearance on 2000-07-07. The listed applicant is Espe Dental AG. The 510(k) number is K001494.

When did MODIFICATION TO PROMPT L-POP receive FDA 510(k) clearance?

MODIFICATION TO PROMPT L-POP received FDA 510(k) clearance on 2000-07-07, under 510(k) number K001494.

Who is the listed applicant for MODIFICATION TO PROMPT L-POP?

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

What is the FDA product code for MODIFICATION TO PROMPT L-POP?

The FDA product code for MODIFICATION TO PROMPT L-POP is KLE.

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Other records listing Espe Dental AG 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.

K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMK011154ELIPAR FREELIGHTK002793KETAC CEM UK002364PROTEMP HK000595DIMENSION PENTA LK000588DIMENSION GARANT L, DIMENSION GARANT L QUICK

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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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