FDA product code EMG: Forceps, Tooth Extractor, Surgical
EMG is the FDA product code for forceps, tooth extractor, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 10 510(k) submissions under EMG, from 7 different applicants. The average 510(k) review took 72 days (median 52). FDA has posted 1 recall for EMG devices.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Tooth Extractor, 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 EMG clearance
Top EMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 4 | 1985-07-01 |
| Hager& Meisinger GmbH | 1 | 2007-04-16 |
| A. Titan Instruments, Inc. | 1 | 2006-06-12 |
| The Huxley Instrument Corp. | 1 | 1985-05-15 |
| Imm Enterprises , Ltd. | 1 | 1984-04-05 |
2 more applicants have EMG clearances. See the full list in Caduvo.
Most recent EMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062130 | Hager& Meisinger GmbH | MEISINGER BENEX, MODEL BE001 | 2007-04-16 | 264 |
| K060691 | A. Titan Instruments, Inc. | EASY X-TRAC SYSTEM | 2006-06-12 | 89 |
| K851708 | Artiberia | 500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA | 1985-07-01 | 67 |
| K851712 | Artiberia | 600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI | 1985-06-11 | 47 |
| K851711 | Artiberia | 600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE | 1985-06-11 | 47 |
Recalls for EMG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-05-21.
Frequently asked questions
What is FDA product code EMG?
EMG is the FDA product code for forceps, tooth extractor, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMG?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMG?
Across 10 cleared submissions the average was 72 days from receipt to decision (median 52).
Which companies have the most EMG clearances?
Artiberia (4); Hager& Meisinger GmbH (1); A. Titan Instruments, Inc. (1); The Huxley Instrument Corp. (1); Imm Enterprises , Ltd. (1).
Have EMG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code EMG
- Run a recall and safety report across every EMG manufacturer
- Watch product code EMG 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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