TERA HARZ DENTURE

Resin, Denture, Relining, Repairing, Rebasing

Graphy Inc.

The following data is part of a premarket notification filed by Graphy Inc. with the FDA for Tera Harz Denture.

Pre-market Notification Details

Device IDK222414
510k NumberK222414
Device Name:TERA HARZ DENTURE
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant Graphy Inc. 603, #617, Ace Gasan Forhu, 225, Gasan Digital 1-ro, Geumcheon-gu, Seoul,  KR 08503
ContactTae-woo Kim
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-08-10
Decision Date2022-08-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800142100598 K222414 000
08800142100574 K222414 000
08800142100550 K222414 000
08800142100536 K222414 000
08800142100512 K222414 000
08800142100499 K222414 000

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