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FDA 510(k)

PSP TEMP - TRAY

K-Number: K853093 · 1985-09-06

ApplicantPsp Dental Co., Ltd.
Decision Date1985-09-06
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PSP TEMP - TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Psp Dental Co., Ltd.. It received FDA 510(k) clearance on 1985-09-06 under 510(k) number K853093. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSP TEMP - TRAY?

PSP TEMP - TRAY is a medical device that received FDA 510(k) clearance on 1985-09-06. The listed applicant is Psp Dental Co., Ltd.. The 510(k) number is K853093.

When did PSP TEMP - TRAY receive FDA 510(k) clearance?

PSP TEMP - TRAY received FDA 510(k) clearance on 1985-09-06, under 510(k) number K853093.

Who is the listed applicant for PSP TEMP - TRAY?

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

What is the FDA product code for PSP TEMP - TRAY?

The FDA product code for PSP TEMP - TRAY is EBH.

Other records listing Psp Dental Co., Ltd. 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.

K853089SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREEK853094EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEAK853092PSP C & B TEMPK853091CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATEK853090CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO

Related Devices (Code: EBH)

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.

K933745PERMAGEN UNIVERSAL BONDING RESINBio-Systems ResearchK930487PALATRAY LC MINTHeraeus Kulzer, Inc.K923979LC TRAY MATERIALDentsply Intl.K923549PALADISC LCHeraeus Kulzer, Inc.K912820POLYESTER RESIN HAND MOLDED TRAYE&D Dental Products, Inc.K905058PALAVIT LKulzer, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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