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First SPEP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012032

by Bisco Inc.

Identifiers

510(k) Number
K012032 FDA 510(k)
FDA Product Code
DYH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3750 FDA 510(k)
Regulation Number
872.3750 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The First SPEP is a self-etching primer system classified as an adhesive, bracket, and tooth conditioner resin. It is designed to etch and prime enamel surfaces, preparing them for the application of direct bonding orthodontic adhesives in orthodontic procedures.

This two-bottle system is supplied as a dental device intended for single-use in orthodontic settings. It is regulated under FDA 510(k) clearance (K012032) and falls under regulation number 872.3750, classified as a Class II device. No information regarding MRI safety or sterility is provided in the specifications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FIRST SPEP (K012032) — FDA 510(k) | Innolitics, FIRST SPEP 510 (k) K012032 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bisco Inc.
FDA Applicant
Bisco, Inc.

Sources (1)

  • FDA 510(k) K012032 24 fields · synced Sep 19, 2026