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

PROPHY ANGLES, R&R

K Number: K780199 · Decision Feb 16, 1978
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
7
Review Days
9

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Basic Information

Device Name
PROPHY ANGLES, R&R
K Number
K780199
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.4200
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Ransom and Randolph
Date Received
February 7, 1978
Decision Date
February 16, 1978
Product Code
EGS
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
EGS Handpiece, Contra- And Right-Angle Attachment, Dental

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K780198 PROPHY CUPS, R&R
K771347 R&R ALSTON CARBIDE BURS
K770598 ENDODONTIC INSTRUMENTS, R&R CUTWELL
K761067 DENTSPLY DIE STONE