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Nouvatec, LLC: FDA-registered device maker in Walnut Spgs, TX, United States, 2 510(k) clearances

Name: Nouvatec, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nouvatec, LLC is registered with the FDA (registration 3012607373) in Walnut Spgs, TX, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 3, 2004. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012607373
Address: 5986 Highway 144, Walnut Spgs, TX, United States, 76690
Owner or operator: Nouvatec LLC (10052407)
Roles: Repackager or relabeler
First device listed: February 11, 2025
Registered through: 2026
Brand names listed: Nouvag AG

Devices it lists

Device	Product code	Class	Role	Source
Drill, Bone, Powered	DZI	2	Repackager or relabeler	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Repackager or relabeler	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Repackager or relabeler	accessdata.fda.gov
Motor, Drill, Electric	HBC	2	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 3, 2004	K042434	MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55	DZI	Substantially Equivalent	NOUVAG AG	accessdata.fda.gov
October 1, 2003	K022505	CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,	EGS	Substantially Equivalent	NOUVAG AG	accessdata.fda.gov

Compare with other makers

Updated November 3, 2004. 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.