Drill, Dental, Intraoral
The Intraoral Dental Drill is a dental device used by dental professionals to cut, shape, or prepare tooth structure and bone in the oral cavity, driven by a powered handpiece. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is DZA and the applicable regulation is 21 CFR 872.4130, under the Dental medical specialty.
Basic Information
- Product Code
- DZA
- Device Class
- FDA class 1
- Regulation Number
- 872.4130
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | Jun 25, 1999 | Substantially Equivalent | W & H DENTALWERK BUERMOOS GMBH |
| K962979 | S-53 INTRORAL DENTAL SYSTEM | Sep 25, 1996 | Substantially Equivalent | DEL MEDICAL SYSTEMS CORP. |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Jan 16, 1996 | Substantially Equivalent | TULSA DENTAL PRODUCTS, LTD. |
| K914724 | ADA SHANK EXTENSION | Jul 27, 1993 | Substantially Equivalent | IMPLANT CORP. OF AMERICA |
| K905418 | GATES GLIDDEN DRILLS | Jul 25, 1991 | Substantially Equivalent | THE HYGENIC CORP. |
| K901097 | FILLOCK REAMER | Apr 25, 1990 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K896149 | ANEST-EZE DENTAL DRILL RA#2 | Jan 19, 1990 | Substantially Equivalent | SIGNATURE ONE PRODUCTS, INC. |
| K884187 | INDENTEC DRILL RA #1 | Dec 22, 1988 | Substantially Equivalent | PHILLIP C. CRAWFORD, D.D.S. |
| K811113 | RIESS-LUHR | Jun 16, 1981 | Substantially Equivalent | ALLOMEDIC |
| K801888 | HANDPIECE, DENTAL | Aug 20, 1980 | Substantially Equivalent | AESCULAP INSTRUMENTS CORP. |
| K801887 | DRILL, DENTAL | Aug 20, 1980 | Substantially Equivalent | AESCULAP INSTRUMENTS CORP. |
| K761275 | AIROTOS LF HANDPIECE | Dec 23, 1976 | Substantially Equivalent | DENTSPLY INTL. |
| K760956 | SURGICAL MICRO DRILL | Nov 19, 1976 | Substantially Equivalent | AMERICAN SAFETY EQUIPMENT CORP. |
FEI Numbers
This FDA classification entry is associated with 193 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 193 registration numbers. Click on an entry to view related FDA registrations.