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FDA 510(k)

DENTAL RUBBER DAM

K-Number: K923157 · 1993-07-22

ApplicantAseptico, Inc.
Decision Date1993-07-22
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL RUBBER DAM is the device name listed in this FDA 510(k) record. The listed applicant is Aseptico, Inc.. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K923157. 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 RUBBER DAM?

DENTAL RUBBER DAM is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Aseptico, Inc.. The 510(k) number is K923157.

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

DENTAL RUBBER DAM received FDA 510(k) clearance on 1993-07-22, under 510(k) number K923157.

Who is the listed applicant for DENTAL RUBBER DAM?

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

What is the FDA product code for DENTAL RUBBER DAM?

The FDA product code for DENTAL RUBBER DAM is EIE.

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Other records listing Aseptico, 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.

K130693AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEMK111078AEU-26L ELCTRONIC ENDODONTIC SYSTEMK101332AMC-20 PORTABLE DENTAL CART MODEL AMC-20K103399GENERAL DENISTRY MOTORK070866ASC-12 PIEZOELECTRIC SCALERK051077E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101

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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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