DZA · Drill, Dental, Intraoral
Dental · 21 CFR 872.4130 · Class 1
Overview
| Product Code | DZA |
|---|---|
| Device Name | Drill, Dental, Intraoral |
| Regulation | 21 CFR 872.4130 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Cleared Devices (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | W&H Dentalwerk Buermoos GmbH | Jun 25, 1999 | SESE |
| K962979 | S-53 INTRORAL DENTAL SYSTEM | Del Medical Systems Corp. | Sep 25, 1996 | SESE |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Tulsa Dental Products, Ltd. | Jan 16, 1996 | SESE |
| K914724 | ADA SHANK EXTENSION | Implant Corp. of America | Jul 27, 1993 | SESE |
| K905418 | GATES GLIDDEN DRILLS | The Hygenic Corp. | Jul 25, 1991 | SESE |
| K901097 | FILLOCK REAMER | Ivoclar North America, Inc. | Apr 25, 1990 | SESE |
| K896149 | ANEST-EZE DENTAL DRILL RA#2 | Signature One Products, Inc. | Jan 19, 1990 | SESE |
| K884187 | INDENTEC DRILL RA #1 | Phillip C. Crawford, D.D.S. | Dec 22, 1988 | SESE |
| K811113 | RIESS-LUHR | Allomedic | Jun 16, 1981 | SESE |
| K801888 | HANDPIECE, DENTAL | Aesculap Instruments Corp. | Aug 20, 1980 | SESE |
| K801887 | DRILL, DENTAL | Aesculap Instruments Corp. | Aug 20, 1980 | SESE |
| K761275 | AIROTOS LF HANDPIECE | Dentsply Intl. | Dec 23, 1976 | SESE |
| K760956 | SURGICAL MICRO DRILL | American Safety Equipment Corp. | Nov 19, 1976 | SESE |
Top Applicants
- Aesculap Instruments Corp. — 2 clearances
- W&H Dentalwerk Buermoos GmbH — 1 clearance
- Tulsa Dental Products, Ltd. — 1 clearance
- The Hygenic Corp. — 1 clearance
- Signature One Products, Inc. — 1 clearance
