FDA product code DZM: Needle, Dental
DZM is the FDA product code for needle, dental. It is a Class I device, regulated under 21 CFR 872.4730 and reviewed by the Dental panel. FDA has cleared 16 510(k) submissions under DZM, from 14 different applicants. The average 510(k) review took 90 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Needle, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.4730 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DZM clearance
Top DZM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Specialites Septodont | 2 | 1991-11-07 |
| Smith & Nephew, Mpl Division | 2 | 1984-03-30 |
| Schiff & Co. | 1 | 1999-04-27 |
| Dentsply Intl. | 1 | 1992-04-28 |
| Aseptic Dental Technologies, Inc. | 1 | 1992-03-09 |
9 more applicants have DZM clearances. See the full list in Caduvo.
Most recent DZM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990511 | Schiff & Co. | X-TIP INTRAOSSEOUS PERFORATOR | 1999-04-27 | 68 |
| K920758 | Dentsply Intl. | JENKER NEEDLE STICK PROTECTOR | 1992-04-28 | 69 |
| K914562 | Aseptic Dental Technologies, Inc. | ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM | 1992-03-09 | 146 |
| K913573 | Specialites Septodont | SAFETY PLUS DENTAL INJECTION NEEDLE | 1991-11-07 | 87 |
| K910475 | Health Technology Systems, Inc. | DENTAL NEEDLE PROTECTIVE SYSTEM | 1991-09-13 | 219 |
Recalls for DZM devices
openFDA lists no recalls for product code DZM.
Frequently asked questions
What is FDA product code DZM?
DZM is the FDA product code for needle, dental. It is a Class I device, regulated under 21 CFR 872.4730 and reviewed by the Dental panel.
What device class is DZM?
Class I, regulation 21 CFR 872.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DZM?
Across 16 cleared submissions the average was 90 days from receipt to decision (median 82).
Which companies have the most DZM clearances?
Specialites Septodont (2); Smith & Nephew, Mpl Division (2); Schiff & Co. (1); Dentsply Intl. (1); Aseptic Dental Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DZM
- Run a recall and safety report across every DZM manufacturer
- Watch product code DZM 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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