Cleared Traditional

K050208 - FRIADENT ESTHETICAP

K050208 is an FDA 510(k) clearance for FRIADENT ESTHETICAP, manufactured by Dentsply International. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K050208 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
137d
Days
Class 2
Risk

K050208 is an FDA 510(k) clearance for the FRIADENT ESTHETICAP. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on June 14, 2005 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 Dentsply International devices

FDA 510(k) Submission Details - K050208

510(k) Number K050208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2005
Decision Date June 14, 2005
Days to Decision 137 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
10d slower than avg
Panel avg: 127d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 533
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K050208.
ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
K052600 · Zimmer Dental, Inc. · Oct 2005
SPI EASY TEMPORARY CAP
K051527 · Thommen Medical AG · Jul 2005
NOBELREPLACE ADAPTER, MODEL 32412
K050444 · Nobel Biocare Uas, Inc. · Jul 2005
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K043042 · Nobel Biocare AB · Nov 2004
PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
K042658 · Nobel Biocare Uas, Inc. · Oct 2004
PROCERA ABUTMENT OCTAGON
K041275 · Nobel Biocare Uas, Inc. · May 2004