510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Creodent Prosthetics Ltd

New York, NY, US

CREODENT PROSTHETICS LTD appears in FDA device records in New York, NY. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Creodent Prosthetics Ltd between 2013 and 2022. The busiest year on record is 2017, with 2. The most recent is 2022, with 2.

Clearances by year, as a table
510(k) clearance decisions for Creodent Prosthetics Ltd, by decision year
YearClearances
20131
20151
20161
20172
20201
20211
20222
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220390CreoDent Solidex Customized Abutment and ScrewNHASubstantially Equivalent
K211427CREOKORREKT AlignersNXCSubstantially Equivalent
K202909CreoDent Solidex Customized AbutmentNHASubstantially Equivalent
K202095CreoDent Solidex Customized Abutment and ScrewNHASubstantially Equivalent
K170100CreoDent Solidex Customized Abutment and ScrewNHASubstantially Equivalent
K162734CreoDent Solidex Customized AbutmentNHASubstantially Equivalent
K160436CreoDent Solidex Custom AbutmentNHASubstantially Equivalent
K150012CreoDent Solidex Customized AbutmentNHASubstantially Equivalent
K113738CREODENT SOLIDEX CUSTOM ABUTMENTNHASubstantially Equivalent

Registered establishments

FDA registered establishments for Creodent Prosthetics Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30097115923009711592CREODENT PROSTHETICS LTD29 W 30th St FL 11th, New York, NY 10001 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain