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3.3MM Accessories

by Nobelpharma USA, Inc. 510(k)

Active United States

510(k) K952448

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952448 Date20 Jun 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 3.3mm Accessories are dental implant accessories designed as components for endosseous, root-form dental implants. These accessories are intended to facilitate the precise placement and fixation of dental implants within the alveolar bone, ensuring stability and proper integration for restorative procedures.

Supplied as single-use items, these accessories are regulated under FDA 510(k) clearance (K952448) and fall under the Implant, Endosseous, Root-form classification (Product Code: DZE). They are intended for use in dental settings and must be handled in accordance with sterile procedures. No MRI safety information or reusable specifications are provided in the regulatory data.

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