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FIRST (K830513)

by Phasealloy

510(k) K830513

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830513 Date9 May 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
First Tm
510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The FIRST (K830513) is a dental device classified under product code EBF, intended for use in dental procedures. It is designed to assist in the preparation or restoration of teeth, adhering to dental regulatory standards for safety and efficacy.

This device is supplied by Phasealloy and has received FDA 510(k) clearance under a traditional review pathway, with a decision date of May 9, 1983. It is intended for single-use or reusable applications in a clinical dental setting, though specific sterility or reuse instructions are not detailed in the provided data. The device is regulated under the Dental advisory committee and remains compliant with applicable U.S. regulatory requirements.

Other devices from Phasealloy

  • Phaseafill

    Class II

Questions

AI-generated answers, 19 Sep 2026

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

  • What is the FIRST™ device primarily used for in dental procedures?

    The FIRST™ (K830513) is designed to assist in the preparation or restoration of teeth, adhering to dental safety and efficacy standards. It falls under product code EBF, which typically includes devices used for dental cutting, shaping, or polishing during restorative work.

  • Is the FIRST™ device intended for single-use or reusable applications?

    The FIRST™ is labeled for either single-use or reusable applications in a clinical dental setting. However, the provided data does not specify sterility requirements or detailed reuse instructions, so facility protocols should be followed to ensure compliance with infection control standards.

  • How was the FIRST™ device cleared by the FDA, and what does that mean for its regulatory status?

    The FIRST™ received FDA 510(k) clearance under a traditional review pathway on May 9, 1983, with a decision code of *SESE* (Substantially Equivalent). This means the FDA determined it is as safe and effective as a legally marketed predicate device, meeting U.S. regulatory requirements for dental devices under product code EBF.

  • What advisory committee oversees the regulatory classification of the FIRST™ device?

    The FIRST™ is regulated under the Dental (DE) Advisory Committee, which provides expert input on dental device submissions. This committee reviews submissions filed under product code EBF to ensure compliance with dental-specific safety and performance standards.