Submission Details
| 510(k) Number | K070127 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2007 |
| Decision Date | March 29, 2007 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02
Mar 2007
Decision
72d
Days
Class 1
Risk
About This 510(k) Submission
K070127 is an FDA 510(k) clearance for the PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02, a Scaler, Periodontic (Class I — General Controls, product code EMN), submitted by Kevin Vu, Dds (San Diego, US). The FDA issued a Cleared decision on March 29, 2007, 72 days after receiving the submission on January 16, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.
Device Classification
| Product Code | EMN — Scaler, Periodontic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4565 |
Manufacturer
Similar Devices — EMN Scaler, Periodontic
K931330 · Minnesota Prophy Power, Inc.
· Jan 1994
K851721 · Artiberia
· Jul 1985
K821786 · Pacific Dental Corp.
· Jul 1982
K781035 · Premier Dental Products Co.
· Jun 1978