Cleared Traditional

K992819 - WAND PLUS

K992819 is an FDA 510(k) clearance for WAND PLUS, manufactured by Spintech, Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K992819 · Spintech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
265d
Days
Class 2
Risk

K992819 is an FDA 510(k) clearance for the WAND PLUS. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Spintech, Inc. (Washington, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 265 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Spintech, Inc. devices

FDA 510(k) Submission Details - K992819

510(k) Number K992819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1999
Decision Date May 11, 2000
Days to Decision 265 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 128d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJI Device Classification - Class 2, Special Controls

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJI Syringe, Cartridge

All 25
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K992819.
MIRAMATIC SAFE SYRINGE SYSTEM
K043322 · Hager Worldwide, Inc. · Jul 2005
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
K002168 · Ronvig Instruments, Ltd. · Oct 2000
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
MINIJECT
K991888 · Spartan Ultrasonics, Inc. · Aug 1999
CCS
K983105 · Dentsply Midwest · Mar 1999
GETTIG STYRL-JECT DELIVERY SYSTEM
K972285 · Gettig Pharmaceutical Instrument Co. · Sep 1997