Data / Medical devices / United States / Dsaart, LLC

Dsaart, LLC: FDA-registered device maker in Carson City, NV, United States, 9 510(k) clearances

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

Dsaart, LLC is registered with the FDA (registration 3003897287) in Carson City, NV, United States. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 23, 2003. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003897287
Address: 2950 Arrowhead Drive Carson City, NV 89706, Carson City, NV, United States, 89706
Owner or operator: DSAART, LLC (9050953)
Roles: Manufacturer
First device listed: January 10, 2008
Registered through: 2026
Brand names listed: Calf Implant, Chin Implant, Dimisil Scar Gel, Gluteal Implant, Malar Implant, Nasal Implant, Pectoral Implant, Silicone Carving Block and more

Devices it lists

Device	Product code	Class	Role	Source
Elastomer, Silicone Block	MIB	2	Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Manufacturer	accessdata.fda.gov
Implant, Malar	LZK	2	Manufacturer	accessdata.fda.gov
Implant, Muscle, Pectoralis	MIC	2	Manufacturer	accessdata.fda.gov
Prosthesis, Chin, Internal	FWP	2	Manufacturer	accessdata.fda.gov
Prosthesis, Nose, Internal	FZE	2	Manufacturer	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
January 23, 2003	K023678	DIMISIL SCAR GEL	MDA	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov
August 26, 2002	K022511	AART CALF IMPLANT	MIB	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov
August 8, 2002	K022223	AART SILICONE SHEETING	MIB	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov
July 16, 2002	K021839	AART GLUTEAL IMPLANT	MIB	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov
July 16, 2002	K021820	AART SILICONE CARVING BLOCK	MIB	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov
July 3, 2002	K021337	AART PECTORALIS IMPLANT	MIC	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov
July 2, 2002	K021419	AART MALAR IMPLANT	LZK	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov
July 2, 2002	K021418	AART NASAL IMPLANT	FZE	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov
July 2, 2002	K021417	AART CHIN IMPLANT	FWP	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 26, 2025	97704	Class II	Ongoing	Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 - Silicone Carving Implant Style 6 Size 2 UDI-DI c	Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2025. 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.