FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273

K Number: K852593 · Decision Jul 24, 1985
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
4
Review Days
35

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
K Number
K852593
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.6510
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Northern Electric Co. Div. of Sunbeam Corp.
Date Received
June 19, 1985
Decision Date
July 24, 1985
Product Code
EFS
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EFS Unit, Oral Irrigation

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (EFS), ordered by most recent decision date.

View all

Other Clearances by Northern Electric Co. Div. of Sunbeam Corp.

K Number Device Name
K860118 SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220
K851220 SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664
K852279 SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201