FDA product code DZS: Capsule, Dental, Amalgam
DZS is the FDA product code for capsule, dental, amalgam. It is a Class I device, regulated under 21 CFR 872.3110 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under DZS, from 3 different applicants. The average 510(k) review took 56 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Capsule, Dental, Amalgam |
| Device class | Class I |
| Regulation | 21 CFR 872.3110 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DZS clearance
Top DZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lee Pharmaceuticals | 2 | 1978-09-20 |
| Syntex Dental Products, Inc. | 1 | 1982-09-14 |
| Johnson & Johnson Professionals, Inc. | 1 | 1980-12-30 |
Most recent DZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822610 | Syntex Dental Products, Inc. | PRECAPSULED DENTAL AMALGAM | 1982-09-14 | 15 |
| K802967 | Johnson & Johnson Professionals, Inc. | DISPERSALLOY-DISPERSED PHASE ALLOY SELF- | 1980-12-30 | 39 |
| K781243 | Lee Pharmaceuticals | MERCURY DISP. CAPSULE | 1978-09-20 | 100 |
| K780966 | Lee Pharmaceuticals | LEE-ALLOY DISPOSABLE CAPSULES | 1978-08-21 | 70 |
Recalls for DZS devices
openFDA lists no recalls for product code DZS.
Frequently asked questions
What is FDA product code DZS?
DZS is the FDA product code for capsule, dental, amalgam. It is a Class I device, regulated under 21 CFR 872.3110 and reviewed by the Dental panel.
What device class is DZS?
Class I, regulation 21 CFR 872.3110. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DZS?
Across 4 cleared submissions the average was 56 days from receipt to decision (median 54).
Which companies have the most DZS clearances?
Lee Pharmaceuticals (2); Syntex Dental Products, Inc. (1); Johnson & Johnson Professionals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DZS
- Run a recall and safety report across every DZS manufacturer
- Watch product code DZS 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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