Cleared Traditional

K983227 - POWER BLOCK

K983227 is an FDA 510(k) clearance for POWER BLOCK, manufactured by Kreativ, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K983227 · Kreativ, Inc. · Dental device
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Dec 1998
Decision
87d
Days
Class 1
Risk

K983227 is an FDA 510(k) clearance for the POWER BLOCK. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Kreativ, Inc. (San Diego, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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 Kreativ, Inc. devices

FDA 510(k) Submission Details - K983227

510(k) Number K983227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1998
Decision Date December 11, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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 - EIE Dam, Rubber

All 10
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K983227.
GC TION GINGIVAL PROTECTOR
K043301 · GC America, Inc. · Jan 2005
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
NIVEOUS LIQUID DAM
K021613 · Shofu Dental Corp. · Jun 2002
FASTDAM
K972775 · Interdent, Inc. · Feb 1998
DENTAL DAM
K954990 · The Hygenic Corp. · Jan 1996
DENTAL RUBBER DAM
K923157 · Aseptico, Inc. · Jul 1993