Cleared Traditional

K082532 - STRAUMANN GUIDED INSTRUMENTS

K082532 is the FDA 510(k) clearance for STRAUMANN GUIDED INSTRUMENTS by Straumann USA. It is a Class 2 Dental device (product code DZI) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K082532 · Straumann USA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
49d
Days
Class 2
Risk

K082532 is an FDA 510(k) clearance for the STRAUMANN GUIDED INSTRUMENTS. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on October 21, 2008 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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 Straumann USA devices

Submission Details

510(k) Number K082532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date October 21, 2008
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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 - DZI Drill, Bone, Powered

All 24
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K082532.
Piezosurgery White
K171326 · Mectron S.P.A. · Apr 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958 · Mectron S.P.A. · Jan 2018
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · Synthes (Usa) · Apr 2009
VARIOSURG
K073678 · Nakanishi, Inc. · Jul 2008
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
K060270 · Linvatec Corp. · Apr 2006
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607 · Linvatec Corp. · Nov 2003