Manufacturer registered with FDA

Open Implants

Santa Ana, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.

FDA owner/operator10089590Manufacturer3 clearances in five years
Device types listed
2
Brands and models
3
510(k) clearances
42020–2025
Markets registered in
1United States
Establishments
1United States
2020: 12021: 12022: 12025: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Open Implants currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
Neodent Grand MorseSherlock Abutment
2023
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Sherlock Accessories
2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Open Implants as the applicant.

Decided510(k)DeviceDevice type
26 Jun 2025K250967SherlockNHA Endosseous Dental Implant Abutment
21 Jun 2022K220482SherlockNHA Endosseous Dental Implant Abutment
30 Nov 2021K212664SherlockNHA Endosseous Dental Implant Abutment
24 Mar 2020K193335SherlockNHA Endosseous Dental Implant Abutment

Registered establishments

EstablishmentLocationWhat it does
OPEN IMPLANTSFDA reg. 3027595870Santa Ana, CA, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10089590). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.