FDA product code DZP: Instrument, Diamond, Dental
DZP is the FDA product code for instrument, diamond, dental. It is a Class I device, regulated under 21 CFR 872.4535 and reviewed by the Dental panel. FDA has cleared 21 510(k) submissions under DZP, from 16 different applicants. The average 510(k) review took 76 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Diamond, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.4535 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DZP clearance
Top DZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shofu Dental Corp. | 4 | 1985-12-27 |
| Beavers Dental, Div. Sybron Canada, Ltd. | 2 | 2012-04-20 |
| Swiss American Metal Craft Corp. | 2 | 1980-12-30 |
| Sophos Technologic | 1 | 1994-09-16 |
| Dunhall Pharmaceuticals, Inc. | 1 | 1994-08-29 |
11 more applicants have DZP clearances. See the full list in Caduvo.
Most recent DZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120037 | Beavers Dental, Div. Sybron Canada, Ltd. | BLUWHITE DIAMOND DENTAL BURS MODIFIED | 2012-04-20 | 106 |
| K943841 | Sophos Technologic | SOPHOS DENTAL DIAMOND | 1994-09-16 | 42 |
| K940908 | Dunhall Pharmaceuticals, Inc. | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS | 1994-08-29 | 186 |
| K934981 | Eare Consulting Service | DENTAL DRILL | 1994-02-03 | 107 |
| K923757 | Alpha Industrializacao DE Metais Ltda. | DENTAL DIAMOND DRILLS | 1993-03-16 | 231 |
Recalls for DZP devices
openFDA lists no recalls for product code DZP.
Frequently asked questions
What is FDA product code DZP?
DZP is the FDA product code for instrument, diamond, dental. It is a Class I device, regulated under 21 CFR 872.4535 and reviewed by the Dental panel.
What device class is DZP?
Class I, regulation 21 CFR 872.4535. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DZP?
Across 21 cleared submissions the average was 76 days from receipt to decision (median 56).
Which companies have the most DZP clearances?
Shofu Dental Corp. (4); Beavers Dental, Div. Sybron Canada, Ltd. (2); Swiss American Metal Craft Corp. (2); Sophos Technologic (1); Dunhall Pharmaceuticals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DZP
- Run a recall and safety report across every DZP manufacturer
- Watch product code DZP 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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