Drill, Dental, Intraoral
Regulation 872.4130
0510(k)s in 12 months (13 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in DZA
| Company | 510(k)s | Recalls |
|---|---|---|
| Aesculap Instruments Corp. | 2 | 0 |
| Allomedic | 1 | 0 |
| American Safety Equipment Corp. | 1 | 0 |
| Biomet 3i, LLC | 0 | 1 |
| Del Medical Systems Corp. | 1 | 0 |
| Dentsply Intl. | 1 | 0 |
| The Hygenic Corp. | 1 | 0 |
| Implant Corp. of America | 1 | 0 |
| Ivoclar North America, Inc. | 1 | 0 |
| Phillip C. Crawford, D.D.S. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 1999 | 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, AT | DZA |
| Sep 25, 1996 | K962979 | S-53 INTRORAL DENTAL SYSTEM Del Medical Systems Corp. | DZA |
| Jan 16, 1996 | K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS Tulsa Dental Products, Ltd. | DZA |
| Jul 27, 1993 | K914724 | ADA SHANK EXTENSION Implant Corp. of America | DZA |
| Jul 25, 1991 | K905418 | GATES GLIDDEN DRILLS The Hygenic Corp. | DZA |
| Apr 25, 1990 | K901097 | FILLOCK REAMER Ivoclar North America, Inc. | DZA |
| Jan 19, 1990 | K896149 | ANEST-EZE DENTAL DRILL RA#2 Signature One Products, Inc. | DZA |
| Dec 22, 1988 | K884187 | INDENTEC DRILL RA #1 Phillip C. Crawford, D.D.S. | DZA |
| Jun 16, 1981 | K811113 | RIESS-LUHR Allomedic | DZA |
| Aug 20, 1980 | K801888 | HANDPIECE, DENTAL Aesculap Instruments Corp. | DZA |
| Aug 20, 1980 | K801887 | DRILL, DENTAL Aesculap Instruments Corp. | DZA |
| Dec 23, 1976 | K761275 | AIROTOS LF HANDPIECE Dentsply Intl. | DZA |
| Nov 19, 1976 | K760956 | SURGICAL MICRO DRILL American Safety Equipment Corp. | DZA |
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