Atlas FDA

DENTAL INSTRUMENTS SCALER

FDA 510(k) clearance K931330 · decided 1994-01-26

Clearance details

K-number
K931330
Device name
DENTAL INSTRUMENTS SCALER
Applicant
Minnesota Prophy Power, Inc.
Decision
Substantially Equivalent
Date received
1993-03-16
Decision date
1994-01-26
Days to decision
316 days
Clearance type
Traditional
Product code
EMN
Device class
1
Regulation number
872.4565
Medical specialty
Dental
Advisory committee
Dental
Location
Lakeville, 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.

RecordFirmDate
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 (K070127)Kevin Vu, Dds2007-03-29
1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS (K851721)Artiberia1985-07-02
BEACH SCALERS (K821786)Pacific Dental Corp.1982-07-06
PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX (K781035)Premier Dental Products Co.1978-06-30

Recalls involving this device

No recalls on record reference this clearance.