Cleared Traditional

Straumann BLX Implant System (K210855) - FDA 510(k) Clearance

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

K210855 · Institut Straumann AG · Dental device
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Jun 2021
Decision
90d
Days
Class 2
Risk

K210855 is an FDA 510(k) clearance for the Straumann BLX Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on June 21, 2021 after a review of 90 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.

View all Institut Straumann AG devices

Submission Details

510(k) Number K210855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2021
Decision Date June 21, 2021
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 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 - DZE Implant, Endosseous, Root-form

All 302
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K210855.
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K203725 · S.I.N. ? Sistema DE Implante Nacional S.A. · Jun 2021
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K210161 · Megagen Implant Co., Ltd. · Jun 2021
Kontact Dental Implant System
K210220 · Biotech Dental, Sas · Jun 2021
MIS Lance+ Conical Connection Dental Implant System
K210886 · Dentsply Sirona · Jun 2021
Dentis s-Clean s-Line Mini
K210080 · Dentis Co., Ltd. · Jun 2021