Indentec Drill Ra #1
FDA 510(k) K884187 · Phillip C. Crawford, D.D.S.
510(k) numberK884187
Submission
- Device name
- Indentec Drill Ra #1
- Applicant
- Phillip C. Crawford, D.D.S.
Boca Raton, FL, US - Received
- October 5, 1988
- Decision date
- December 22, 1988
- 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 |
| K905418 | Gates Glidden DrillsDZA · Traditional | The Hygenic Corp. | 07/25/1991SE |
| 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 |
| 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 |
Questions and answers
When was Indentec Drill Ra #1 cleared by the FDA?
Indentec Drill Ra #1 (K884187) received a 510(k) decision of Substantially Equivalent on December 22, 1988, 78 days after the submission was received.
What is the product code of K884187?
The FDA product code is DZA – Drill, Dental, Intraoral, a Class I (low risk) device regulated under 21 CFR 872.4130.