Cleared Traditional

K101225 - PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1

K101225 is an FDA 510(k) clearance for PROMIMIC DENTAL IMPLANT, manufactured by Promimic AB. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K101225 · Promimic AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
267d
Days
Class 2
Risk

K101225 is an FDA 510(k) clearance for the PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTA.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Promimic AB (Goteborg, SE). The FDA issued a Cleared decision on January 25, 2011 after a review of 267 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Promimic AB devices

FDA 510(k) Submission Details - K101225

510(k) Number K101225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2010
Decision Date January 25, 2011
Days to Decision 267 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1185
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K101225.
OSSEOFUSE DENTAL IMPLANT SYSTEM
K110577 · Dynamic Innovations, Inc. · Jul 2011
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K102034 · Blue Sky Bio, LLC · Apr 2011
ET III SA ULTRA WIDE SYSTEM
K103537 · Hiossen, Inc. · Mar 2011
INCLUSIVE MINI IMPLANT
K100932 · Prismatik Dentalcraft, Inc. · Dec 2010
NOBEL ACTIVE 3.0
K102436 · Nobel Biocare AB · Dec 2010
GC AADVA IMPLANT SYSTEM
K093749 · GC America, Inc. · Dec 2010