FDA product code EBL: Pin, Retentive And Splinting, And Accessory Instruments
EBL is the FDA product code for pin, retentive and splinting, and accessory instruments. It is a Class I device, regulated under 21 CFR 872.3740 and reviewed by the Dental panel. FDA has cleared 11 510(k) submissions under EBL, from 11 different applicants. The average 510(k) review took 89 days (median 41). FDA has posted 1 recall for EBL devices.
Classification
| Field | Value |
|---|---|
| Device name | Pin, Retentive And Splinting, And Accessory Instruments |
| Device class | Class I |
| Regulation | 21 CFR 872.3740 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EBL clearance
Top EBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cbs Intl. B.V. | 1 | 2000-11-09 |
| Dentauraum, Inc. | 1 | 1995-07-19 |
| The Thera Group | 1 | 1993-11-22 |
| Swiss Precision Mfg. Corp. | 1 | 1990-02-14 |
| Nanzee Dental Products | 1 | 1989-12-20 |
6 more applicants have EBL clearances. See the full list in Caduvo.
Most recent EBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K002693 | Cbs Intl. B.V. | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) | 2000-11-09 | 72 |
| K952868 | Dentauraum, Inc. | DENTAURUM JACKET CROWN & ROOT POSTS | 1995-07-19 | 27 |
| K924376 | The Thera Group | ROOT CANAL POST | 1993-11-22 | 451 |
| K895283 | Swiss Precision Mfg. Corp. | PROSTHETIC RESTORATION DEVICE | 1990-02-14 | 174 |
| K895758 | Nanzee Dental Products | PLASTIC TOOTH REINFORCEMENT KIT | 1989-12-20 | 85 |
Recalls for EBL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-03-18.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code EBL?
EBL is the FDA product code for pin, retentive and splinting, and accessory instruments. It is a Class I device, regulated under 21 CFR 872.3740 and reviewed by the Dental panel.
What device class is EBL?
Class I, regulation 21 CFR 872.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EBL?
Across 11 cleared submissions the average was 89 days from receipt to decision (median 41).
Which companies have the most EBL clearances?
Cbs Intl. B.V. (1); Dentauraum, Inc. (1); The Thera Group (1); Swiss Precision Mfg. Corp. (1); Nanzee Dental Products (1).
Have EBL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code EBL
- Run a recall and safety report across every EBL manufacturer
- Watch product code EBL 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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