FDA product code EIE: Dam, Rubber
EIE is the FDA product code for dam, rubber. It is a Class I device, regulated under 21 CFR 872.6300 and reviewed by the Dental panel. FDA has cleared 33 510(k) submissions under EIE, from 26 different applicants. The average 510(k) review took 105 days (median 87). FDA has posted 1 recall for EIE devices.
Classification
| Field | Value |
|---|---|
| Device name | Dam, Rubber |
| Device class | Class I |
| Regulation | 21 CFR 872.6300 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
510(k) clearances per year for EIE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 270 |
Compare with all 510(k) review times · Search every EIE clearance
Top EIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elastomade Accessories Sdn Bhd | 3 | 1995-10-19 |
| Aseptico, Inc. | 3 | 1993-07-22 |
| Britesmile, Inc. | 2 | 2004-04-02 |
| The Hygenic Corp. | 2 | 1996-01-26 |
| Dental Dam, Inc. | 2 | 1988-03-18 |
21 more applicants have EIE clearances. See the full list in Caduvo.
Most recent EIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182118 | Mavrik Dental Systems, Ltd. | armor LC | 2019-05-03 | 270 |
| K151945 | Denali Corporation | Triumph Resin Dam | 2016-02-18 | 219 |
| K050318 | Bioenvelop Agro, Inc. | BARI-KAD PACKING DEVICE | 2005-03-04 | 23 |
| K043301 | GC America, Inc. | GC TION GINGIVAL PROTECTOR | 2005-01-25 | 56 |
| K040797 | Britesmile, Inc. | BRITESMILE MASKING CREAM | 2004-04-02 | 4 |
Recalls for EIE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-12-11.
Frequently asked questions
What is FDA product code EIE?
EIE is the FDA product code for dam, rubber. It is a Class I device, regulated under 21 CFR 872.6300 and reviewed by the Dental panel.
What device class is EIE?
Class I, regulation 21 CFR 872.6300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIE?
Across 33 cleared submissions the average was 105 days from receipt to decision (median 87).
Which companies have the most EIE clearances?
Elastomade Accessories Sdn Bhd (3); Aseptico, Inc. (3); Britesmile, Inc. (2); The Hygenic Corp. (2); Dental Dam, Inc. (2).
Have EIE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code EIE
- Run a recall and safety report across every EIE manufacturer
- Watch product code EIE 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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