Submission Details
| 510(k) Number | K872215 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 09, 1987 |
| Decision Date | July 10, 1987 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
Cleared
Traditional
PERIO-TEST
Jul 1987
Decision
31d
Days
Class 1
Risk
About This 510(k) Submission
K872215 is an FDA 510(k) clearance for the PERIO-TEST, a Gauge, Depth, Instrument, Dental (Class I — General Controls, product code EIL), submitted by Dr. Bernard Loewenthal (Portsmouth, US). The FDA issued a Cleared decision on July 10, 1987, 31 days after receiving the submission on June 9, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.
Device Classification
| Product Code | EIL — Gauge, Depth, Instrument, Dental |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4565 |
Manufacturer
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