Gates Glidden Drills
FDA 510(k) K905418 · The Hygenic Corp.
510(k) numberK905418
Submission
- Device name
- Gates Glidden Drills
- Applicant
- The Hygenic Corp.
Akron, OH, US - Received
- December 4, 1990
- Decision date
- July 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code DZA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984508 | Surgical Contra-Angle Handpieces, Models 975 AE,979 E/Km, 985 Ae, 986 Ae, 988 E/Km and…DZA · Traditional | W&H Dentalwerk Buermoos GmbH | 06/25/1999SE |
| K962979 | S-53 Introral Dental SystemDZA · Traditional | Del Medical Systems Corp. | 09/25/1996SE |
| K954790 | Profile Nickel Titanium Rotary InstrumentsDZA · Traditional | Tulsa Dental Products, Ltd. | 01/16/1996SE |
| K914724 | Ada Shank ExtensionDZA · Traditional | Implant Corp. of America | 07/27/1993SE |
| K901097 | Fillock ReamerDZA · Traditional | Ivoclar North America, Inc. | 04/25/1990SE |
| K896149 | Anest-Eze Dental Drill RA#2DZA · Traditional | Signature One Products, Inc. | 01/19/1990SE |
| K884187 | Indentec Drill Ra #1DZA · Traditional | Phillip C. Crawford, D.D.S. | 12/22/1988SE |
| K811113 | Riess-LuhrDZA · Traditional | Allomedic | 06/16/1981SE |
| K801888 | Handpiece, DentalDZA · Traditional | Aesculap Instruments Corp. | 08/20/1980SE |
| K801887 | Drill, DentalDZA · Traditional | Aesculap Instruments Corp. | 08/20/1980SE |
More from Aesculap Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K954990 | Dental DamEIE · Traditional | 01/26/1996SE |
| K930764 | Endo-Ice-Pulp Tester-ThermalEAT · Traditional | 05/27/1993SE |
| K911225 | Tray DoughKGS · Traditional | 04/17/1991SE |
| K905640 | Solid Core Gutta Percha CarrierEKS · Traditional | 03/05/1991SE |
| K900301 | Novus Bonding AgentEBI · Traditional | 05/15/1990SE |
| K900844 | WedjetsEIE · Traditional | 04/16/1990SE |
| K894092 | Dental Endodontic Cement (Modification)KIF · Traditional | 01/10/1990SE |
| K881826 | Endo-IceEAT · Traditional | 08/23/1988SN |
| K873644 | Pulp PenEAT · Traditional | 10/27/1987SE |
| K863393 | EndocaterLQY · Traditional | 06/11/1987SE |
Questions and answers
When was Gates Glidden Drills cleared by the FDA?
Gates Glidden Drills (K905418) received a 510(k) decision of Substantially Equivalent on July 25, 1991, 233 days after the submission was received.
What is the product code of K905418?
The FDA product code is DZA – Drill, Dental, Intraoral, a Class I (low risk) device regulated under 21 CFR 872.4130.