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FDA 510(k)

MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL

K-Number: K030776 · 2003-05-09

ApplicantDiscus Dental, Inc.
Decision Date2003-05-09
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Discus Dental, Inc.. It received FDA 510(k) clearance on 2003-05-09 under 510(k) number K030776. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL?

MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL is a medical device that received FDA 510(k) clearance on 2003-05-09. The listed applicant is Discus Dental, Inc.. The 510(k) number is K030776.

When did MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL receive FDA 510(k) clearance?

MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL received FDA 510(k) clearance on 2003-05-09, under 510(k) number K030776.

Who is the listed applicant for MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL?

The FDA 510(k) record lists Discus Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL?

The FDA product code for MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL is ELW.

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Other records listing Discus Dental, Inc. as applicant

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K073518FLASHLITE REBEL*K062176RELIEF ACP ORAL CARE GELK052090SPLASH! IMPRESSION MATERIAL DEVICEK051776PROTEGE ULTRASONIC INSERTK033785PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDEK040053PRECISION VPS IMPRESSION MATERIAL

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Related Devices (Code: ELW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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