FDA product code DYN: Mouthpiece, Saliva Ejector
DYN is the FDA product code for mouthpiece, saliva ejector. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel. FDA has cleared 18 510(k) submissions under DYN, from 18 different applicants. The average 510(k) review took 67 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Mouthpiece, Saliva Ejector |
| Device class | Class I |
| Regulation | 21 CFR 872.6640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DYN clearance
Top DYN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Terraflex | 1 | 1994-08-17 |
| Asa Instruments S.R.L. | 1 | 1994-03-21 |
| J.H.Orsing AB | 1 | 1994-03-21 |
| Glenroe Technologies | 1 | 1993-03-31 |
| Hygoplastic, Inc. | 1 | 1992-05-11 |
13 more applicants have DYN clearances. See the full list in Caduvo.
Most recent DYN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940769 | Terraflex | DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR | 1994-08-17 | 180 |
| K935758 | J.H.Orsing AB | HYGOFLEX SALIVA-EJECTOR | 1994-03-21 | 115 |
| K935616 | Asa Instruments S.R.L. | SALIVA EJECTOR DISPOSABLE | 1994-03-21 | 119 |
| K924211 | Glenroe Technologies | EJECTOR | 1993-03-31 | 223 |
| K920492 | Hygoplastic, Inc. | HIGH VAC | 1992-05-11 | 98 |
Recalls for DYN devices
openFDA lists no recalls for product code DYN.
Frequently asked questions
What is FDA product code DYN?
DYN is the FDA product code for mouthpiece, saliva ejector. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel.
What device class is DYN?
Class I, regulation 21 CFR 872.6640. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DYN?
Across 18 cleared submissions the average was 67 days from receipt to decision (median 48).
Which companies have the most DYN clearances?
Terraflex (1); Asa Instruments S.R.L. (1); J.H.Orsing AB (1); Glenroe Technologies (1); Hygoplastic, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DYN
- Run a recall and safety report across every DYN manufacturer
- Watch product code DYN 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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