Prosthetic devices · 21 CFR 872 Subpart D
Preformed Clasp
FDA device type “Clasp, Preformed”.
- Companies listing it
- 2416 makers
- Brands and models
- 34
- 510(k) clearances
- 80 in five years
- FDA name
- Clasp, Preformed
510(k) clearances per year, 1976–2026
Companies that list EHP
24 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Yamahachi Dental Mfg. Co. | Japan | Maker | Weldenz | 3 | 2026 |
| Ortho Organizers, Inc. | United States | Maker | Ball Clasps · Multiple orthodontic clasps | 8 | 2025 |
| Leone S.P.A. | Italy | Maker | PREFORMED CLASP | 4 | 2025 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | CLASP · Preformed wire accessories | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| Rmo, Inc. | United States | Maker | Preformed wire clasp; RM Ball Retainer Clasp, Adams Clasp, J Clasp, Hawley Wire | 1 | 1990 |
| The Myerson Company Limited | Trinidad & Tobago | Maker | DurAcetal | 1 | 2017 |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Lingual bars L/M/S · Occlusal flat wire L/M/S · Palatal bars L/M/S | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Clasp · Clasp Preformed · Noninium clasp · Noninium labial arch · +2 | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | CLASP, PREFORMED | — | — |
| Scheu-Dental GmbH | Germany | Maker | Clasps preformed, Ball clasps, arrow clasps, J clasps, Voss clasps | — | — |
| Fseven Dental Technology Zhuhai Co.,ltd | China | Maker | CLASP,PREFORMED | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | CLASP, PREFORMED | — | — |
| Jin Hsiang Enterprise Co., Ltd. | Taiwan | Maker | — | — | — |
| Ricomed LLC | United States | Maker | RICOmed preformed wires | — | — |
| CreoDent Prosthetics LTD | United States | Repacker / relabeler | Clasp | 9 | 2022 |
| Keystone Industries | United States | Contract manufacturer | Itsoclear Clasps · Keystone Industries Wire Clasps | 2 | 2025 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Summit Clasps | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Ball Clasps sizes 028 to 036 · Preformed Adam Clasp sizes 5 to 12 mm / Kits | — | — |
| Forestadent Usa | United States | Repacker / relabeler | CLASP | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Contract manufacturer | Great Lakes Adams clasps · Great Lakes Arrow clasps · Great Lakes Ball clasps | — | — |
| Olson Dental Laboratory, Inc. | United States | Repacker / relabeler | Duracetal | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 29 Aug 2002 | K022032 | ACETAL | Inovativ, LLC |
| 7 Jan 1999 | K983558 | ACETAL DENTAL/PREFORMED CLASP | Dentamax, Inc. |
| 10 Feb 1998 | K974622 | DENTAL D | Modern Dental Laboratory USA, LLC |
| 11 Dec 1995 | K955946 | ACETAL DENTAL/PREFORMED CLASP | Pressing DI Monticelli Rag. Stefano |
| 11 Dec 1995 | K954971 | ACETAL DENTAL/PREFORMED CLASP | B & H Technical Services , Ltd. |
| 13 Jun 1986 | K854765 | INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH | C&C Systems, Inc. |
| 20 May 1980 | K800575 | VACUDENT LUMIX 70 | Vacudent Sales Corp. |
| 20 May 1980 | K800574 | VACUDENT LUMIX 65 | Vacudent Sales Corp. |
Official records: FDA product classification for EHP · 21 CFR 872.3285.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026