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FDA 510(k)

B-SYSTEM SILICONE

K-Number: K982917 · 1998-10-16

ApplicantSybron Dental Specialties, Inc.
Decision Date1998-10-16
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

B-SYSTEM SILICONE is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1998-10-16 under 510(k) number K982917. 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 B-SYSTEM SILICONE?

B-SYSTEM SILICONE is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K982917.

When did B-SYSTEM SILICONE receive FDA 510(k) clearance?

B-SYSTEM SILICONE received FDA 510(k) clearance on 1998-10-16, under 510(k) number K982917.

Who is the listed applicant for B-SYSTEM SILICONE?

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

What is the FDA product code for B-SYSTEM SILICONE?

The FDA product code for B-SYSTEM SILICONE is ELW.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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Related Devices (Code: ELW)

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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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