Data / Medical devices / United States / Smart Denture Conversions, LLC

Smart Denture Conversions, LLC: FDA-registered device maker in Apex, NC, United States, 8 510(k) clearances

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

Smart Denture Conversions, LLC is registered with the FDA (registration 3015527825) in Apex, NC, United States. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 17, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015527825
Address: 1800 N Salem St Suite 104 and 105, Apex, NC, United States, 27523
Owner or operator: Smart Denture Conversions, LLC (10060412)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: May 8, 2019
Registered through: 2026
Brand names listed: Prosthetic Screw, Paltop (IHex)

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer, Specification developer	accessdata.fda.gov
Anchor, Preformed	EJX	1	Manufacturer, Specification developer	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Repackager or relabeler	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	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 17, 2025	K242064	Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)	NHA	Substantially Equivalent	Smart Denture Conversions, LLC	accessdata.fda.gov
October 13, 2023	K223697	MRI compatibility for existing BioHorizons dental implants and abutments	DZE	Substantially Equivalent	BioHorizons Implant Systems, Inc.	accessdata.fda.gov
August 10, 2022	K221381	KDG Abutments	NHA	Substantially Equivalent	Keystone Dental, Inc.	accessdata.fda.gov
March 18, 2019	K183518	Preat Abutments	NHA	Substantially Equivalent	Preat Corporation	accessdata.fda.gov
February 24, 2018	K173643	Trilor Disks, Blocks and Arches	EBF	Substantially Equivalent	Bioloren S.R.L.	accessdata.fda.gov
August 8, 2017	K170588	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
April 20, 2012	K112795	PALTOP DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Paltop Advanced Dental Solutions, Ltd.	accessdata.fda.gov
November 30, 2009	K092341	LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION	NHA	Substantially Equivalent	Biomet 3i, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 17, 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.