Fillock Reamer
FDA 510(k) K901097 · Ivoclar North America, Inc.
510(k) numberK901097
Submission
- Device name
- Fillock Reamer
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- March 7, 1990
- Decision date
- April 25, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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| 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 |
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Questions and answers
When was Fillock Reamer cleared by the FDA?
Fillock Reamer (K901097) received a 510(k) decision of Substantially Equivalent on April 25, 1990, 49 days after the submission was received.
What is the product code of K901097?
The FDA product code is DZA – Drill, Dental, Intraoral, a Class I (low risk) device regulated under 21 CFR 872.4130.