510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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3Shape A/S

Copenhagen Hovedstaden, DK

3Shape A/S appears in FDA device records in Copenhagen Hovedstaden, DK. FDA records list 8 510(k) clearances between and , no PMA records and 3 registered establishments. 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
8
PMA records
0
Recall records
0
Registered establishments
3

510(k) clearance history

FDA records hold 8 510(k) clearances for 3Shape A/S between 2016 and 2020. The busiest year on record is 2016, with 2. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for 3Shape A/S, by decision year
YearClearances
20162
20172
20182
20191
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200100Abutment DesignPNPSubstantially Equivalent
K1919113Shape Splint DesignPNNSubstantially Equivalent
K180941Ortho SystemPNNSubstantially Equivalent
K171634Ortho SystemPNNSubstantially Equivalent
K163677Ortho SystemPNNSubstantially Equivalent
K161884Ortho SystemMQCSubstantially Equivalent
K1514553Shape Abutment Designer SoftwarePNPSubstantially Equivalent
K1520863Shape Ortho SystemPNNSubstantially Equivalent

Registered establishments

FDA registered establishments for 3Shape A/S, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
300594040030059404003Shape A/SHolmens Kanal 7, Copenhagen Hovedstaden 1060 DK2026
301519348630151934863Shape Inc.2800 Perimeter Park Drive, Morrisville, NC 27560 US2026
301072855830107285583shape inc430 Mountain Avenue, Suite 205, New Providence, NJ 07974 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