Cleared Traditional

PROBE TIP/PERI PROBE/PERI PROBE COMP.

K936221 · Pd International AB · Dental

Aug 1994

Decision

217d

Days

Class 1

Risk

About This 510(k) Submission

K936221 is an FDA 510(k) clearance for the PROBE TIP/PERI PROBE/PERI PROBE COMP., a Probe, Periodontic (Class I — General Controls, product code EIX), submitted by Pd International AB (Sloane, SE). The FDA issued a Cleared decision on August 1, 1994, 217 days after receiving the submission on December 27, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K936221 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 1993
Decision Date	August 01, 1994
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement