Prosthetic devices · 21 CFR 872 Subpart D
Retentive and Splinting Pin and Accessory Instruments
FDA device type “Pin, Retentive And Splinting, And Accessory Instruments”.
- Companies listing it
- 5436 makers
- Brands and models
- 81
- 510(k) clearances
- 110 in five years
- FDA name
- Pin, Retentive And Splinting, And Accessory Instruments
510(k) clearances per year, 1976–2026
Companies that list EBL
54 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Blue Sky Bio, LLC | United States | Maker | Guide Fixation Pin, Parallel Pin Starter | 20 | 2024 |
| Biotem Co., Ltd. | South Korea | Maker | Fixture Pin · Parallel Pin | 6 | 2023 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | IMICRYL Interdental Brush, ROLENE Prophylaxis Brushes, ROLENE Bonding Brushes, PANORA Plaque Covers | 5 | 2022 |
| Coltene/Whaledent AG | Switzerland | Maker | Bondent® Dentin Bonding Pins · Max® Restorative Pins · TMS Link Plus® · TMS Link Plus® Minim · +10 | 45 | 2022 |
| bredent GmbH & Co. KG | Germany | Maker | — | 3 | 2024 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Dental Lab Materials Brass Dowel pins | 1 | 2025 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | METALPIN | 11 | 2021 |
| Hager Worldwide, Inc. | United States | Maker | Almore Markley Wire | 2 | 2005 |
| Abracadabra Implants Ltd. | Israel | Maker | RP150 - Retentive Post M1.50 · RP160 - Retentive Post M1.60 · RP172 - Retentive Post 1-72 UNF · RP200 - Retentive Post M20 · +2 | 1 | 2021 |
| Osung Mnd Co Ltd | South Korea | Maker | ORCRL · ORCRM | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Bar hinge · Bar sleeve · dent attach · Jacket Crown Posts · +1 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Dental Lab Materials Brass Dowel pins | — | — |
| MC Bio s.r.l. | Italy | Maker | G-Special Set · G-Special Set II · GBR Modular Tack Set · Harv Tack SP Set · +5 | — | — |
| Dentatus AB | Sweden | Maker | Luminex | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Brass dowel pins | — | — |
| Erskine Dental | Australia | Maker | — | — | — |
| Hager & Werken | Germany | Maker | PERFECT SPLINT | — | — |
| Accumedix, Inc. | United States | Maker | Dental Implant Accessory Instruments | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho Crown | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| Hospimed Mfg | Pakistan | Maker | Hand Tools | — | — |
| CM Instrumente GmbH | Germany | Maker | AND ACCESSORY INSTRUMENTS · CM -Instrumente · PIN · RETENTIVE AND SPLINTING | — | — |
| Edenta Etablissement | Liechtenstein | Maker | AND ACCESSORY INSTRUMENTS · PIN · RETENTIVE AND SPLINTING | — | — |
| Greens Surgicals Private Limited | India | Maker | GREENS | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Dufner Instrumente GmbH | Germany | Maker | PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS | — | — |
| Harald Nordin S.A. | Switzerland | Maker | — | — | — |
| Cynosure LLC | United States | Maker | Nubond Post, Screw | — | — |
| LA MAISON DENTAIRE / Medirel SA | Switzerland | Maker | Perfomat · Splintmat | — | — |
| Fairfax MEDICAL PRODUCTS Ltd | United Kingdom | Maker | Stabilok | — | — |
| Lenjoy Medical Engineering Inc | United States | Maker | COMFY SPLINTS · PRODUCTS | — | — |
| Mahe Medical USA | United States | Maker | MAHE | — | — |
| dentistry elevated | United States | Maker | — | — | — |
| MedCare Solutions GmbH | Germany | Maker | — | — | — |
| Rudolf Storz GmbH | Germany | Maker | — | — | — |
| Pulpdent Corporation | United States | Manufacturer | PerfoMat · Rainbow Wedges · SplintMat | 107 | 2021 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | Parallel-A-Prep | 4 | 2004 |
| Engineered Endodontics | United States | Repacker / relabeler | Filpin | 1 | 2019 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ULTRAXDENT | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dental Accessory | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Dental Accessory | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Stabilok | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Mountain Dental Lab Service Inc | United States | Repacker / relabeler | MOUNTAIN DENTAL SERVICES | — | — |
| Onestopdentalstudio Inc | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Mountain Dental Services | Hong Kong SAR China | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 9 Nov 2000 | K002693 | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) | Cbs Intl. B.V. |
| 19 Jul 1995 | K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | Dentauraum, Inc. |
| 22 Nov 1993 | K924376 | ROOT CANAL POST | The Thera Group |
| 14 Feb 1990 | K895283 | PROSTHETIC RESTORATION DEVICE | Swiss Precision Mfg. Corp. |
| 20 Dec 1989 | K895758 | PLASTIC TOOTH REINFORCEMENT KIT | Nanzee Dental Products |
| 9 Aug 1988 | K883074 | ELGILOY | Dale T. Dupuis |
| 14 Oct 1986 | K863831 | VIVADENT FILPIN | Vivadent (Usa), Inc. |
| 27 Dec 1984 | K844457 | SECURIPIN | Hughes Int'L, Inc. |
| 28 Apr 1983 | K830773 | MARKLEY THREADED WIRE | Almore Intl., Inc. |
| 30 Aug 1982 | K822412 | REINFORCING PIN | Filhol |
| 21 Oct 1976 | K760723 | SAFE-T-PINS RETENTIVE PIN SYSTEM | Parkell, Inc |
Official records: FDA product classification for EBL · 21 CFR 872.3740.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026