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FDA 510(k)

DENTAL BIB

K-Number: K891053 · 1989-04-12

ApplicantDispomed, Inc.
Decision Date1989-04-12
Product CodeFYB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DENTAL BIB is the device name listed in this FDA 510(k) record. The listed applicant is Dispomed, Inc.. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K891053. The device is classified under product code FYB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL BIB?

DENTAL BIB is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Dispomed, Inc.. The 510(k) number is K891053.

When did DENTAL BIB receive FDA 510(k) clearance?

DENTAL BIB received FDA 510(k) clearance on 1989-04-12, under 510(k) number K891053.

Who is the listed applicant for DENTAL BIB?

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

What is the FDA product code for DENTAL BIB?

The FDA product code for DENTAL BIB is FYB.

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 Dispomed, 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.

K892748PATIENT EXAM GLOVES (MFG. AMMATEX)K891054NON-STERILE GAUZE SPONGEK891058DENTAL GOWNK891052SPLASH GUARD GOGGLEK891056SURGICAL CONE MASKK891051SURGICAL FACE MASK-EAR LOOP

View all 7 devices →

Related Devices (Code: FYB)

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.

K911921DISPOSABLE ISOLATION GOWNLiaoning-Usa Corp.K891820DISPOSABLE MEDICAL GOWNSBioshield, Inc.K803171PROCEDURE & RECOVERY PATIENT SUITAlba Health CareK801570SHIELD DISP. PATIENTS PONCHO GOWNSAmerican Convertors Div., American PharmasealK771929PEDIATRICS GOWNConvertors

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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