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510(k) K780400

DEN-Z-ORB by Nice-Pak Products, Inc. — Product Code KHR

K780400 is an FDA 510(k) premarket notification submitted by Nice-Pak Products, Inc. for the device "DEN-Z-ORB". The FDA issued a decision of Substantially Equivalent on March 27, 1978. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050. Nice-Pak Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorber, Saliva, Paper
Device Class
Class I
Regulation Number
872.6050
Review Panel
DE
Submission Type

Other clearances by Nice-Pak Products, Inc.

  • K974768 — PDI STERILE LUBRICATING JELLY (January 16, 1998)
  • K840342 — PDI PREPMASTER WET PACK PATIENT PREP KIT (March 27, 1984)
  • K840343 — PDI PREPMASTER WET PACK VAGINAL-X21477 (March 27, 1984)
  • K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE (March 26, 1984)
  • K833549 — PDI SURGICAL SCRUB/BRUSH T150-70 (November 28, 1983)
  • K810337 — PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 (February 26, 1981)
  • K781539 — ISO-CARE KIT (November 3, 1978)
  • K780279 — ICE-PAK, PDI (April 10, 1978)

Other clearances for product code KHR

  • K980783 — SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (April 21, 1998)
  • K954068 — GENERAL HYGIENE KIT (November 8, 1995)
  • K953812 — GAUZE SPONGE (October 2, 1995)
  • K891054 — NON-STERILE GAUZE SPONGE (May 1, 1989)
  • K891354 — ORTHODONTIC COTTON ROLL HOLDERS (April 17, 1989)
  • K890734 — DRY TIPS (March 10, 1989)
  • K870383 — ALGINATE WOOL FIBER (April 30, 1987)
  • K850988 — BOVO MOISTURE GUARD (April 16, 1985)
  • K771908 — ISO-SHIELD SALIVA ABSORBERS (November 7, 1977)

FDA data resources