FDA · official record K992868Substantially Equivalent

DENTAPURE DP40 CARTRIDGE

Name: DENTAPURE DP40 CARTRIDGE — FDA K992868
Creator: Mrlb Intl., Inc.
Keywords: DENTAPURE DP40 CARTRIDGE, DENTAPURE DP40 CARTRIDGE, K992868, EIA, FDA

United StatesEIAMrlb Intl., Inc.

Verified

Official record identity

FDA application number: K992868
Decision date: September 07, 1999
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Mrlb Intl., Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 1999-08-26
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.