Cleared Traditional

Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA (K220751) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220751 · Institut Straumann AG · Dental device
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Jun 2022
Decision
79d
Days
Class 2
Risk

K220751 is an FDA 510(k) clearance for the Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA. 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 Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on June 2, 2022 after a review of 79 days - a notably fast clearance cycle.

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: 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 Institut Straumann AG devices

Submission Details

510(k) Number K220751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2022
Decision Date June 02, 2022
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Straumann USA, LLC
Jennifer M Jackson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 315
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K220751.
Dentis s-Clean Abutment Mini
K220440 · Dentis Co., Ltd. · Jun 2022
Straumann TLX Variobase C
K220878 · Institut Straumann AG · Jun 2022
PrimeLOC Attachment System
K220612 · Innovative Product Brands, Inc. · Jun 2022
Neoss Individual Prosthetics
K211396 · Neoss, Ltd. · May 2022
High Retention Attachment System
K220252 · Zest Anchors, LLC · Apr 2022
TLX SRAs and TLX Gold Abutments
K213063 · Institut Straumann AG · Apr 2022