Cleared Traditional

PRAMA White Implant Systems (K180365) - FDA 510(k) Clearance

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

K180365 · Sweden & Martina S.P.A. · Dental device
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Jul 2019
Decision
511d
Days
Class 2
Risk

K180365 is an FDA 510(k) clearance for the PRAMA White Implant Systems. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sweden & Martina S.P.A. (Due Carrare, IT). The FDA issued a Cleared decision on July 8, 2019 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Sweden & Martina S.P.A. devices

Submission Details

510(k) Number K180365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date July 08, 2019
Days to Decision 511 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
384d slower than avg
Panel avg: 127d · This submission: 511d
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 Peers - DZE Implant, Endosseous, Root-form

All 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K180365.
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