FDA product code EJG: Forceps, Rubber Dam Clamp

EJG is the FDA product code for forceps, rubber dam clamp. It is a Class I device, regulated under 21 CFR 872.6300 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EJG. The average 510(k) review took 29 days (median 29). FDA has posted 4 recalls for EJG devices.

Classification

FieldValue
Device nameForceps, Rubber Dam Clamp
Device classClass I
Regulation21 CFR 872.6300
Review panelDE — Dental
Medical specialtyDental
Premarket route510(k) exempt
GMP exemptYes

Compare with all 510(k) review times · Search every EJG clearance

Top EJG applicants

ApplicantClearancesLatest
Hygienic Dental Mfg., Co., The11978-05-12

Most recent EJG clearances

510(k)ApplicantDeviceDecision dateReview days
K780743Hygienic Dental Mfg., Co., TheCLAMP FORCEPS1978-05-1229

Recalls for EJG devices

4 product recalls in 1 recall events; 0 initiated in the last five years and 4 still open. Most recent: 2020-06-03.

YearRecalls
20204

Frequently asked questions

What is FDA product code EJG?

EJG is the FDA product code for forceps, rubber dam clamp. It is a Class I device, regulated under 21 CFR 872.6300 and reviewed by the Dental panel.

What device class is EJG?

Class I, regulation 21 CFR 872.6300. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code EJG?

Across 1 cleared submissions the average was 29 days from receipt to decision (median 29).

Which companies have the most EJG clearances?

Hygienic Dental Mfg., Co., The (1).

Have EJG devices been recalled?

Yes: 4 product recalls across 1 recall events; the most recent began 2020-06-03.

Next steps

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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