FDA product code LCN: Scraper, Tongue
LCN is the FDA product code for scraper, tongue. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel. FDA has cleared 31 510(k) submissions under LCN, from 30 different applicants. The average 510(k) review took 68 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Scraper, Tongue |
| Device class | Class I |
| Regulation | 21 CFR 872.6855 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LCN clearance
Top LCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arkay Co. | 2 | 1984-11-23 |
| Stellar Labs, Inc. | 1 | 1999-09-23 |
| Oralgiene USA, Inc. | 1 | 1999-05-04 |
| Unik Products, Inc. | 1 | 1999-01-14 |
| Custom Medical Arts, Inc. | 1 | 1998-11-18 |
25 more applicants have LCN clearances. See the full list in Caduvo.
Most recent LCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992270 | Stellar Labs, Inc. | MIRACLEBREATH TONGUE CLEANER | 1999-09-23 | 79 |
| K990344 | Oralgiene USA, Inc. | ORALGIENE TONGUE CLEANER | 1999-05-04 | 89 |
| K983683 | Unik Products, Inc. | UNIK TONGUE CLEANER | 1999-01-14 | 86 |
| K983087 | Custom Medical Arts, Inc. | BREATHTIQUE TONGUE SCRAPER | 1998-11-18 | 76 |
| K981808 | Breathaid, LLC | BREATHAID TONGUE SCRAPER | 1998-08-11 | 82 |
Recalls for LCN devices
openFDA lists no recalls for product code LCN.
Frequently asked questions
What is FDA product code LCN?
LCN is the FDA product code for scraper, tongue. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel.
What device class is LCN?
Class I, regulation 21 CFR 872.6855. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LCN?
Across 31 cleared submissions the average was 68 days from receipt to decision (median 70).
Which companies have the most LCN clearances?
Arkay Co. (2); Stellar Labs, Inc. (1); Oralgiene USA, Inc. (1); Unik Products, Inc. (1); Custom Medical Arts, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCN
- Run a recall and safety report across every LCN manufacturer
- Watch product code LCN 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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