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Mega Bite Registration - Dental Bite Registration Material

FDA 510(k)

Class II (US FDA 510(k))

510(k) K030776

by Discus Dental, Inc.

Identifiers

510(k) Number
K030776 FDA 510(k)
FDA Product Code
ELW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3660 FDA 510(k)
Regulation Number
872.3660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a dental bite registration material used for making accurate occlusal records. It is a super-rigid VPS (vinyl polysiloxane) material designed to record centric relation and centric occlusion with optimal viscosity, texture, and rigidity, providing low shrinkage and high stability for precise dental impressions.

The material is supplied for use in dental clinical settings to establish occlusal accuracy, with a working time allowing clinicians to achieve accurate records in approximately 55 seconds. It is a single-use, non-sterile impression material classified as a Class II medical device under FDA regulation number 872.3660, with product code ELW, and was cleared via the traditional 510(k) pathway (K030776) as substantially equivalent to a predicate device.

Frequently asked questions

What is MEGA BITE REGISTRATION used for?

MEGA BITE REGISTRATION is a dental bite registration material used to make accurate occlusal records, specifically to record centric relation and centric occlusion in dental clinical settings.

How is MEGA BITE REGISTRATION supplied and is it sterile or single-use?

MEGA BITE REGISTRATION is supplied as a non-sterile, single-use impression material intended for one-time use in dental clinical settings to ensure occlusal accuracy.

What are the key material properties and working time of MEGA BITE REGISTRATION?

MEGA BITE REGISTRATION is a super-rigid VPS (vinyl polysiloxane) material with optimal viscosity, texture, and rigidity, providing low shrinkage and high stability, with a working time of approximately 55 seconds.

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: Mega Bite Registration - Dental Bite Registration Material (K030776 ..., Mega Bite Registration - Dental Bite Registration Material 510 (k) FDA ..., Mega Bite SPD1370 Rigid Bite Registration - Henry Schein Dental, Mega Bite (Den-Mat) | Dental Product | Pearson Dental

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Discus Dental, Inc.

Sources (1)

  • FDA 510(k) K030776 24 fields · synced Sep 27, 2026