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510(k) K760404

BI-CENTRIC SYSTEM by Pelton & Crane Co. — Product Code KLC

K760404 is an FDA 510(k) premarket notification submitted by Pelton & Crane Co. for the device "BI-CENTRIC SYSTEM". The FDA issued a decision of Substantially Equivalent on August 23, 1976. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Pelton & Crane Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1976
Date Received
August 9, 1976
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 Pelton & Crane Co.

  • K171872 — P50 Series Dental Operative Unit and Accessories (April 26, 2018)
  • K143696 — Spirit (September 18, 2015)
  • K972249 — ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD (September 12, 1997)
  • K972168 — SIDEXIS DIGITAL RADIOGRAPHY SYSTEM (September 5, 1997)
  • K945117 — DELTA (February 28, 1997)
  • K962071 — SPIRIT S1/S2 (August 6, 1996)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K950299 — CEREC 2 (May 23, 1995)
  • K946187 — SPIRIT II AND SPIRIT TREATMENT CENTER (March 1, 1995)
  • K950030 — HELIODENT MD (February 3, 1995)

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