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FDA 510(k)

DENTAL DAM SILICONE

K-Number: K961472 · 1996-08-07

ApplicantWorldwide Dental, Inc.
Decision Date1996-08-07
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL DAM SILICONE is the device name listed in this FDA 510(k) record. The listed applicant is Worldwide Dental, Inc.. It received FDA 510(k) clearance on 1996-08-07 under 510(k) number K961472. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL DAM SILICONE?

DENTAL DAM SILICONE is a medical device that received FDA 510(k) clearance on 1996-08-07. The listed applicant is Worldwide Dental, Inc.. The 510(k) number is K961472.

When did DENTAL DAM SILICONE receive FDA 510(k) clearance?

DENTAL DAM SILICONE received FDA 510(k) clearance on 1996-08-07, under 510(k) number K961472.

Who is the listed applicant for DENTAL DAM SILICONE?

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

What is the FDA product code for DENTAL DAM SILICONE?

The FDA product code for DENTAL DAM SILICONE is EIE.

Related Clinical Trials

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.

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Other records listing Worldwide Dental, Inc. as applicant

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.

K945077INSTRUMENT,FILLING,PLASTIC,DENTALK940785MOUTH PROPSK770407SHIELD, DENTAL X-RAY, PROTECTIVE

Related Devices (Code: EIE)

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.

K182118armor LCMavrik Dental Systems, Ltd.K151945Triumph Resin DamDenali CorporationK050318BARI-KAD PACKING DEVICEBioenvelop Agro, Inc.K043301GC TION GINGIVAL PROTECTORGC America, Inc.K040797BRITESMILE MASKING CREAMBritesmile, Inc.K022522PULPDENT PUTTY DAMPulpdent Corporation

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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