Cleared Traditional

K110778 - BIODENTA CUSTOMIZED ABUTMENT

K110778 is an FDA 510(k) clearance for BIODENTA CUSTOMIZED ABUTMENT, manufactured by Biodenta Swiss AG. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K110778 · Biodenta Swiss AG · Dental device
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Jul 2011
Decision
130d
Days
Class 2
Risk

K110778 is an FDA 510(k) clearance for the BIODENTA CUSTOMIZED ABUTMENT. 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 Biodenta Swiss AG (Berneck, St.Gallen, CH). The FDA issued a Cleared decision on July 29, 2011 after a review of 130 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 Biodenta Swiss AG devices

FDA 510(k) Submission Details - K110778

510(k) Number K110778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2011
Decision Date July 29, 2011
Days to Decision 130 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
3d slower than avg
Panel avg: 127d · This submission: 130d
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 559
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