510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Whitepeaks Dental Solutions GmbH

Hamminkeln North Rhine-Westphalia, DE

WHITEPEAKS DENTAL SOLUTIONS GMBH appears in FDA device records in Hamminkeln North Rhine-Westphalia, DE. FDA records list 3 510(k) clearances between and , no PMA records and 2 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
3
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 3 510(k) clearances for Whitepeaks Dental Solutions GmbH in 2024.

Clearances by year, as a table
510(k) clearance decisions for Whitepeaks Dental Solutions GmbH, by decision year
YearClearances
20243
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K233064Copra SupremeEIHSubstantially Equivalent
K232952Copran ZriEIHSubstantially Equivalent
K233158Copra Smile, Copra Supreme HyperionEIHSubstantially Equivalent

Registered establishments

FDA registered establishments for Whitepeaks Dental Solutions GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30094094733009409473WHITEPEAKS DENTAL SOLUTIONS GMBHWeikenrott 17, Hamminkeln North Rhine-Westphalia 46499 DE2026
30141755093014175509WHITEPEAKS DENTAL SOLUTIONS INC.8 The Green, Dover, DE 19901 US2026No device listings on this registration

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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