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FDA 510(k)

MODIFICATION OF PROMPT L-POP

K-Number: K992048 · 1999-08-16

ApplicantEspe Dental AG
Decision Date1999-08-16
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF 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 1999-08-16 under 510(k) number K992048. 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 OF PROMPT L-POP?

MODIFICATION OF PROMPT L-POP is a medical device that received FDA 510(k) clearance on 1999-08-16. The listed applicant is Espe Dental AG. The 510(k) number is K992048.

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

MODIFICATION OF PROMPT L-POP received FDA 510(k) clearance on 1999-08-16, under 510(k) number K992048.

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

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

Related Clinical Trials

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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 HK001494MODIFICATION TO PROMPT L-POPK000595DIMENSION PENTA L

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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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