FDA product code EMH: Forceps, Rongeur, Surgical
EMH is the FDA product code for forceps, rongeur, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under EMH, from 7 different applicants. The average 510(k) review took 51 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Rongeur, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EMH clearance
Top EMH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 2 | 1989-01-27 |
| Walter Lorenz Surgical, Inc. | 1 | 1986-02-28 |
| Artiberia | 1 | 1985-06-11 |
| Imm Enterprises , Ltd. | 1 | 1984-03-06 |
| C.B.S. Biotechnics, Inc. | 1 | 1984-02-27 |
2 more applicants have EMH clearances. See the full list in Caduvo.
Most recent EMH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890255 | Kinetic Medical Products | BONE RONGEUR, SINGLE-ACTION | 1989-01-27 | 9 |
| K890256 | Kinetic Medical Products | BONE RONGEUR, DOUBLE-ACTION | 1989-01-27 | 9 |
| K854887 | Walter Lorenz Surgical, Inc. | MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT | 1986-02-28 | 84 |
| K851710 | Artiberia | 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC | 1985-06-11 | 47 |
| K834190 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #8 15 | 1984-03-06 | 106 |
Recalls for EMH devices
openFDA lists no recalls for product code EMH.
Frequently asked questions
What is FDA product code EMH?
EMH is the FDA product code for forceps, rongeur, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMH?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMH?
Across 8 cleared submissions the average was 51 days from receipt to decision (median 34).
Which companies have the most EMH clearances?
Kinetic Medical Products (2); Walter Lorenz Surgical, Inc. (1); Artiberia (1); Imm Enterprises , Ltd. (1); C.B.S. Biotechnics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EMH
- Run a recall and safety report across every EMH manufacturer
- Watch product code EMH 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times