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FDA 510(k)

ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS

K-Number: K952628 · 1995-10-19

ApplicantElastomade Accessories Sdn Bhd
Decision Date1995-10-19
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS is the device name listed in this FDA 510(k) record. The listed applicant is Elastomade Accessories Sdn Bhd. It received FDA 510(k) clearance on 1995-10-19 under 510(k) number K952628. 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 ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS?

ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS is a medical device that received FDA 510(k) clearance on 1995-10-19. The listed applicant is Elastomade Accessories Sdn Bhd. The 510(k) number is K952628.

When did ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS receive FDA 510(k) clearance?

ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS received FDA 510(k) clearance on 1995-10-19, under 510(k) number K952628.

Who is the listed applicant for ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS?

The FDA 510(k) record lists Elastomade Accessories Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS?

The FDA product code for ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS is EIE.

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Other records listing Elastomade Accessories Sdn Bhd 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.

K942992ROYAL SHIELD RUBBER DAMSK905470STANDARD RUBBER DAM WITH OR WITHOUT FRAMES

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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