510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Elos MedTech Pinol a/S

Goerloese Hovedstaden, DK

ELOS MEDTECH PINOL A/S appears in FDA device records in Goerloese Hovedstaden, DK. FDA records list 13 510(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
13
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 13 510(k) clearances for Elos MedTech Pinol a/S between 2018 and 2026. The busiest year on record is 2020, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Elos MedTech Pinol a/S, by decision year
YearClearances
20181
20191
20203
20211
20221
20232
20242
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253774Elos Accurate® Denture Fixation SystemNHASubstantially Equivalent
K251497Elos Accurate Hybrid BaseNHASubstantially Equivalent
K242025Elos Accurate® Hybrid Base™NHASubstantially Equivalent
K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentNHASubstantially Equivalent
K231307Elos Accurate Customized AbutmentNHASubstantially Equivalent
K230317Elos Accurate Hybrid BaseNHASubstantially Equivalent
K222044Elos Accurate Customized AbutmentNHASubstantially Equivalent
K201860Elos Accurate Hybrid BaseNHASubstantially Equivalent
K191919Elos Accurate Hybrid BaseNHASubstantially Equivalent
K191890Elos Accurate Customized AbutmentNHASubstantially Equivalent
K192457Elos Accurate Customized AbutmentNHASubstantially Equivalent
K190299Elos Accurate® Customized AbutmentNHASubstantially Equivalent
K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewNHASubstantially Equivalent

Registered establishments

FDA registered establishments for Elos MedTech Pinol a/S, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30076896893007689689ELOS MEDTECH PINOL A/SEngvej 33, Goerloese Hovedstaden DK3330 DK2026

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