FDA product code DZA: Drill, Dental, Intraoral
DZA is the FDA product code for drill, dental, intraoral. It is a Class I device, regulated under 21 CFR 872.4130 and reviewed by the Dental panel. FDA has cleared 13 510(k) submissions under DZA, from 12 different applicants. The average 510(k) review took 119 days (median 56). FDA has posted 3 recalls for DZA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Drill, Dental, Intraoral |
| Device class | Class I |
| Regulation | 21 CFR 872.4130 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DZA clearance
Top DZA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aesculap Instruments Corp. | 2 | 1980-08-20 |
| W&H Dentalwerk Buermoos GmbH | 1 | 1999-06-25 |
| Del Medical Systems Corp. | 1 | 1996-09-25 |
| Tulsa Dental Products, Ltd. | 1 | 1996-01-16 |
| Implant Corp. of America | 1 | 1993-07-27 |
7 more applicants have DZA clearances. See the full list in Caduvo.
Most recent DZA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K984508 | W&H Dentalwerk Buermoos GmbH | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | 1999-06-25 | 189 |
| K962979 | Del Medical Systems Corp. | S-53 INTRORAL DENTAL SYSTEM | 1996-09-25 | 56 |
| K954790 | Tulsa Dental Products, Ltd. | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | 1996-01-16 | 89 |
| K914724 | Implant Corp. of America | ADA SHANK EXTENSION | 1993-07-27 | 648 |
| K905418 | The Hygenic Corp. | GATES GLIDDEN DRILLS | 1991-07-25 | 233 |
Recalls for DZA devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-14.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DZA?
DZA is the FDA product code for drill, dental, intraoral. It is a Class I device, regulated under 21 CFR 872.4130 and reviewed by the Dental panel.
What device class is DZA?
Class I, regulation 21 CFR 872.4130. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DZA?
Across 13 cleared submissions the average was 119 days from receipt to decision (median 56).
Which companies have the most DZA clearances?
Aesculap Instruments Corp. (2); W&H Dentalwerk Buermoos GmbH (1); Del Medical Systems Corp. (1); Tulsa Dental Products, Ltd. (1); Implant Corp. of America (1).
Have DZA devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-04-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DZA
- Run a recall and safety report across every DZA manufacturer
- Watch product code DZA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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