VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247

FDA 510(k) clearance K090519 · decided 2009-04-15

Clearance details

K-number

K090519

Device name

VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247

Applicant

3M Company

Decision

Substantially Equivalent

Date received

2009-02-26

Decision date

2009-04-15

Days to decision

48 days

Clearance type

Special

Product code

LBH

Device class

2

Regulation number

872.3260

Medical specialty

Dental

Advisory committee

Dental

Location

St Paul, MN, US

Third-party review

No

Expedited review

No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant