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Prosthetic devices · 21 CFR 872 Subpart D

Preformed Anchor

FDA device type “Anchor, Preformed”.

FDA codeEJXClass121 CFR872.3130Pathway510(k) exempt
Companies listing it
1510 makers
Brands and models
26
510(k) clearances
10 in five years
FDA name
Anchor, Preformed
2015: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EJX

15 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerStraumann Dental Implant System2122026
Paltop Advanced Dental Solutions Inc.United StatesMaker—72025
Smart Denture Conversions, LLCUnited StatesMaker—22026
Rhein'83 SrlItalyMakerKEF4MAEF 4 EASY FIX T-BASE h6 · KEF4MEF 4 EASY FIX T-BASE h4 · KEF4MLEF 4 EASY FIX T-BASE h9 · KMASRF KIT EASY FIX T-BASE h.6 · +342018
RODO Medical, Inc.United StatesMakerSmileclip32020
Cendres+Metaux SASwitzerlandMakerCM LOC22020
Nobil Metal S p AItalyMakerLV KON · LV KON PLUS——
Changsha Nice Medical Instrument Limited CompanyChinaMakerNiceortho Anchor, Preformed——
Primo Medical Group, IncUnited StatesMakerPreformed Anchor——
Nextcon InternationalPakistanMaker———
Dentsply Sirona, Inc.United StatesContract manufacturer—1482026
Nobel Biocare Services AGSwitzerlandContract manufacturerCM LOC942026
Keystone IndustriesUnited StatesContract manufacturerFrego Strengthener · Keystone Industries Grid Strengtheners · Keystone Industries Lingual Bars · Keystone Industries Mesh Strengtheners · +122025
Sweden & Martina INCUnited StatesListerEASY FIX CASTABLE SLEEVE · KIT EASY FIX · KIT SEEGER · LOCKING SCREW · +1——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerAngelus——

510(k) clearances

Decided510(k)DeviceApplicant
2 Jan 2015K133088ZX-27M&M Dental Studio, Inc.

Official records: FDA product classification for EJX · 21 CFR 872.3130.

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