Cleared Traditional

K102822 - IMPLANT-ONE SYSTEM

K102822 is an FDA 510(k) clearance for IMPLANT-ONE SYSTEM, manufactured by Custom Dental Implants, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K102822 · Custom Dental Implants, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
104d
Days
Class 2
Risk

K102822 is an FDA 510(k) clearance for the IMPLANT-ONE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Custom Dental Implants, Inc. (Chesterland, US). The FDA issued a Cleared decision on January 10, 2011 after a review of 104 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K102822

510(k) Number K102822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2010
Decision Date January 10, 2011
Days to Decision 104 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
24d faster than avg
Panel avg: 128d · This submission: 104d
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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K102822.
ASTRA TECH IMPLANT SYSTEM
K101732 · Astra Tech AB · Feb 2011
NEODENT IMPLANT SYSTEM
K101945 · Jjgc Industria E Comercio DE Materiais Dentarios S · Jan 2011
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 · Promimic AB · Jan 2011
CERAROOT IMPLANT SYSTEM
K093595 · Oral Iceberg S.L. · Jan 2011
INCLUSIVE MINI IMPLANT
K100932 · Prismatik Dentalcraft, Inc. · Dec 2010
COWELL IMPLANT SYSTEM
K100850 · Cowellmedi Co., Ltd. · Dec 2010
K102822 · IMPLANT-ONE SYSTEM
Download PDF FDA Summary Custom Dental Implant…