FDA product code EBO: Denture Repair Kit
EBO is the FDA product code for denture repair kit. It is a Class II device, regulated under 21 CFR 872.3570 and reviewed by the Dental panel. FDA has cleared 7 510(k) submissions under EBO, from 6 different applicants. The average 510(k) review took 112 days (median 119).
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Denture Repair Kit |
| Device class | Class II |
| Regulation | 21 CFR 872.3570 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EBO clearance
Top EBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Laurentian Laboratories | 2 | 1984-02-27 |
| Tooth Aid Lab, Inc. | 1 | 1985-07-02 |
| Advanced Bio Systems, Inc. | 1 | 1985-06-19 |
| Camdent Laboratories | 1 | 1982-04-09 |
| Professional Dental Studios | 1 | 1982-04-09 |
1 more applicants have EBO clearances. See the full list in Caduvo.
Most recent EBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850927 | Tooth Aid Lab, Inc. | COMPLETE DENTURE REPAIR KIT | 1985-07-02 | 119 |
| K844480 | Advanced Bio Systems, Inc. | DENTAL ORAL CARE SYSTEMS & COMPONENTS | 1985-06-19 | 212 |
| K833057 | Laurentian Laboratories | UNIVERSAL FIX-A-PLATE | 1984-02-27 | 173 |
| K833056 | Laurentian Laboratories | UNIVERSAL LINE-A-PLATE | 1984-02-27 | 173 |
| K820685 | Camdent Laboratories | DENTURE ADJUSTMENT KIT | 1982-04-09 | 29 |
Recalls for EBO devices
openFDA lists no recalls for product code EBO.
Frequently asked questions
What is FDA product code EBO?
EBO is the FDA product code for denture repair kit. It is a Class II device, regulated under 21 CFR 872.3570 and reviewed by the Dental panel.
What device class is EBO?
Class II, regulation 21 CFR 872.3570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EBO?
Across 7 cleared submissions the average was 112 days from receipt to decision (median 119).
Which companies have the most EBO clearances?
Laurentian Laboratories (2); Tooth Aid Lab, Inc. (1); Advanced Bio Systems, Inc. (1); Camdent Laboratories (1); Professional Dental Studios (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EBO
- Run a recall and safety report across every EBO manufacturer
- Watch product code EBO 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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