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510(k) K880475

SKEMA (DENTAL UNIT) by Alpine Dental Equipment Co. — Product Code KLC

K880475 is an FDA 510(k) premarket notification submitted by Alpine Dental Equipment Co. for the device "SKEMA (DENTAL UNIT)". The FDA issued a decision of Substantially Equivalent on September 23, 1988. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Alpine Dental Equipment Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1988
Date Received
February 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Dental, With Operative Unit
Device Class
Class I
Regulation Number
872.6250
Review Panel
DE
Submission Type

Other clearances by Alpine Dental Equipment Co.

  • K880474 — AREA (DENTAL CHAIR) (September 23, 1988)
  • K854647 — POLO DENTAL UNIT (June 5, 1986)
  • K854643 — SOLAR (March 14, 1986)
  • K854642 — SOLAR CART (March 14, 1986)
  • K854645 — GOLD AIR, GOLD LIGHT (March 12, 1986)
  • K854641 — SOLAR F (March 10, 1986)
  • K854741 — X-RANGE 65 (March 6, 1986)
  • K854646 — VEGA DENTAL OPERATING LIGHT (March 6, 1986)
  • K854644 — MANTA DENTAL CHAIR (January 23, 1986)

Other clearances for product code KLC

  • K233921 — Luvis Chair (LC700C) (September 6, 2024)
  • K151987 — DCI Edge Dental Chair with Operative Unit (June 1, 2016)
  • K071353 — FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (December 14, 2007)
  • K971063 — OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR (June 3, 1997)
  • K963209 — PROSTYLE COMPACT (October 24, 1996)
  • K942870 — ULTIMA 2 DENTAL CHAIR (February 27, 1995)
  • K940950 — KAVO SYSTEMATICA 1060 (December 29, 1994)
  • K925567 — E 4000 DENTAL OPERATING CHAIR (March 10, 1994)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K925119 — A-DEC 1040 CHAIR (January 31, 1994)

FDA data resources