Cleared Traditional

K990511 - X-TIP INTRAOSSEOUS PERFORATOR

K990511 is an FDA 510(k) clearance for X-TIP INTRAOSSEOUS PERFORATOR, manufactured by Schiff & Co.. The device is a Class 1 Dental device with product code DZM cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K990511 · Schiff & Co. · Dental device
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Apr 1999
Decision
68d
Days
Class 1
Risk

K990511 is an FDA 510(k) clearance for the X-TIP INTRAOSSEOUS PERFORATOR. Classified as Needle, Dental (product code DZM), Class I - General Controls.

Submitted by Schiff & Co. (West Cadwell, US). The FDA issued a Cleared decision on April 27, 1999 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Schiff & Co. devices

FDA 510(k) Submission Details - K990511

510(k) Number K990511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1999
Decision Date April 27, 1999
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

DZM Device Classification - Class 1, General Controls

Product Code DZM Needle, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DZM Needle, Dental

All 7
Devices cleared under the same product code (DZM) and FDA review panel - the closest regulatory comparables to K990511.
JENKER NEEDLE STICK PROTECTOR
K920758 · Dentsply Intl. · Apr 1992
SAFETY PLUS DENTAL INJECTION NEEDLE
K913573 · Specialites Septodont · Nov 1991
DENTAL NEEDLE (CARTRIDGE TYPE)
K870921 · Churchill Corp. · Apr 1987
TERUMO DENTAL NEEDLES
K864970 · Terumo Medical Corp. · Mar 1987
EXEL DENTAL NEEDLE
K861150 · Exel Intl. · Apr 1986
SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE
K851524 · Specialites Septodont · Sep 1985