Data / Medical devices / United States / NDX Paramount Dental Laboratory

NDX Paramount Dental Laboratory: FDA-registered device maker in Sacramento, CA, United States, 11 510(k) clearances

Name: NDX Paramount Dental Laboratory FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

NDX Paramount Dental Laboratory is registered with the FDA (registration 3012690648) in Sacramento, CA, United States. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 5, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012690648
Address: 1851 Heritage Lane, Ste 148, Sacramento, CA, United States, 95815
Owner or operator: National Dentex LLC (9052467)
Roles: Repackager or relabeler
First device listed: February 1, 2008
Registered through: 2026
Brand names listed: DESS Ti Base Abutments, Dentures, full, Dentures, partial, Prosthesis, orthodontic, Restoration, base metal, Restoration, noble metal, Restoration, porcelain, Restoration, porcelain-fused-to-metal and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Repackager or relabeler	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Repackager or relabeler	accessdata.fda.gov
Dentures, Full	NSL	N	Repackager or relabeler	accessdata.fda.gov
Dentures, Partial	NSK	N	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Orthodontic	NSR	N	Repackager or relabeler	accessdata.fda.gov
Restoration, Base Metal	NSQ	N	Repackager or relabeler	accessdata.fda.gov
Restoration, Noble Metal	NSJ	N	Repackager or relabeler	accessdata.fda.gov
Restoration, Porcelain	NSP	N	Repackager or relabeler	accessdata.fda.gov
Restoration, Porcelain-Fused-To-Metal	NSO	N	Repackager or relabeler	accessdata.fda.gov
Restoration, Resin, Crown And Bridge	NSN	N	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 5, 2024	K242340	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
August 26, 2024	K240982	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
April 24, 2024	K240208	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
March 9, 2023	K221301	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
October 27, 2022	K222288	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
March 11, 2022	K212628	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
December 10, 2021	K212577	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
August 4, 2021	K203464	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
November 10, 2019	K191986	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
June 15, 2018	K173908	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
August 8, 2017	K170588	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov

Compare with other makers

Updated November 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.