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510(k) K953191

MODEL A15-101 by Beaverstate Dental, Inc. — Product Code EAY

K953191 is an FDA 510(k) premarket notification submitted by Beaverstate Dental, Inc. for the device "MODEL A15-101". The FDA issued a decision of Substantially Equivalent on September 5, 1995. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Beaverstate Dental, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1995
Date Received
June 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Fiber Optic, Dental
Device Class
Class I
Regulation Number
872.4620
Review Panel
DE
Submission Type

Other clearances by Beaverstate Dental, Inc.

  • K953192 — MODEL A15-103 (September 5, 1995)

Other clearances for product code EAY

  • K953192 — MODEL A15-103 (September 5, 1995)
  • K935718 — JEDENTAL VLC DENTAL CURING LIGHT (January 26, 1994)
  • K871816 — STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM (August 3, 1987)
  • K831976 — POWER OPTIC (August 12, 1983)
  • K831824 — DENTAL ELECTRONIC/S.B.R TRADING BU HAND (August 11, 1983)
  • K820907 — DENTISCOPE (May 5, 1982)
  • K812605 — FIBER OPTIC LIGHT SOURCE I (October 2, 1981)
  • K802684 — HELIOMAT (November 24, 1980)
  • K802716 — DEN-MAT FIBER OPTIC HALOGEN LIGHT (November 12, 1980)
  • K801591 — FIBER OPTIC ILLUMINATOR (July 21, 1980)

FDA data resources