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FDA 510(k)

STERILE DENTAL ROLL

K-Number: K812709 · 1981-10-23

ApplicantMedspec Corp.
Decision Date1981-10-23
Product CodeEFN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERILE DENTAL ROLL is the device name listed in this FDA 510(k) record. The listed applicant is Medspec Corp.. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812709. The device is classified under product code EFN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE DENTAL ROLL?

STERILE DENTAL ROLL is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Medspec Corp.. The 510(k) number is K812709.

When did STERILE DENTAL ROLL receive FDA 510(k) clearance?

STERILE DENTAL ROLL received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812709.

Who is the listed applicant for STERILE DENTAL ROLL?

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

What is the FDA product code for STERILE DENTAL ROLL?

The FDA product code for STERILE DENTAL ROLL is EFN.

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Other records listing Medspec Corp. 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.

K813012STERILE BASIN SETSK812710STERILE LAPAROTOMY SPONGES-X-RAY DETECTK812707STERILE DISSECTOR SPONGES-X-RAY DETECTK812711STERILE GAUZE PADS 12PLYK810071STERILE SILICONE TUBINGK810069STERILE AIRWAY

View all 15 devices →

Related Devices (Code: EFN)

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.

K872810STRUNG DENTAL ROLLSAmerican Silk Sutures, Inc.K871464MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STERMedgroup Enterprises, Inc.K863764COTTON ROLLS, NON-STERILEThe Medical Group, Inc.K861338DENTAL COTTON ROLLS, STERILE AND NON-STERILEIntl. Verbandstoff-Fabrik SchaffhauK861727COTTON FILLED GAUZE SPONGES 2 X 2Cross Country Paper Products Corp.K843539TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-Molnlycke A/S Hospital Products

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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