DENTIST WITH ASSISTANT PACK— 510(k) K940864

Name: FDA 510(k) clearance K940864
Creator: U.S. Food and Drug Administration
Published: 1994-08-02

Substantially Equivalent

Sterile Concepts, Inc.

FDA 510(k) clearance K940864 for DENTIST WITH ASSISTANT PACK, Substantially Equivalent on 1994-08-02. Applicant: Sterile Concepts, Inc.. Device class: 1.

Clearance details

Applicant: Sterile Concepts, Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1994-02-23
Decision date: 1994-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIA

view all

K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)2026-08-07
K251626 — Midmark Dental Delivery System2025-11-03
K251491 — K5 Cart, K5 Mount, K5 Swing2025-07-17
K243130 — Integral Dental Unit2025-06-27
K242611 — Integral Dental Units2025-05-27

More clearances from Sterile Concepts, Inc.

view all

K951231 — ORTHOPEDIC PACKS1995-12-01
K951081 — OB/GYN PACKS1995-11-13
K952539 — RADIOLOGY PACKS1995-07-14
K951478 — GENERAL AND PLASTIC SURGERY PACKS1995-06-13
K944139 — DENTAL HYGIENE TRAY1994-12-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.