Data / Medical devices / United States / Implant Logistics / AMS Micromedical

Implant Logistics / AMS Micromedical: FDA-registered device maker in Sparta, WI, United States, 4 510(k) clearances

Name: Implant Logistics / AMS Micromedical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Implant Logistics / AMS Micromedical is registered with the FDA (registration 3008870565) in Sparta, WI, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 15, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008870565
Address: 711 Spartan Drive, Sparta, WI, United States, 54656
Owner or operator: Implant Logistics / AMS Micromedical (10035440)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: February 28, 2011
Registered through: 2026
Brand names listed: Implant Logistics, Inc, Implant Logistics, Inc; Implant-One, Implant Logistics, Inc; Implant-One Multi-Unit Abutment, Implant-One

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Blade-Form Endosseous Dental Implant	NRQ	2	Contract manufacturer	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Contract manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Contract 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
August 15, 2023	K231455	Implant-One System	NHA	Substantially Equivalent	Implant Logistics, Inc.	accessdata.fda.gov
March 23, 2023	K212394	Implant-One Multi-Unit Abutment	NHA	Substantially Equivalent	Implant Logistics, Inc.	accessdata.fda.gov
November 29, 2018	K173701	Implant-One System	DZE	Substantially Equivalent	Implant Logistics, Inc.	accessdata.fda.gov
January 10, 2011	K102822	IMPLANT-ONE SYSTEM	DZE	Substantially Equivalent	Custom Dental Implants, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 15, 2023. 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.