510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nobel Biocare Services AG

Kloten Zurich, CH

Nobel Biocare Services AG appears in FDA device records in Kloten Zurich, CH. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Nobel Biocare Services AG between 2021 and 2023. The busiest year on record is 2021, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nobel Biocare Services AG, by decision year
YearClearances
20212
20222
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231219NobelZygoma PureSet™ TrayKCTSubstantially Equivalent
K220339Esthetic Abutments Nobel Biocare N1NHASubstantially Equivalent
K220048NobelProcera Zirconia N1 BaseNHASubstantially Equivalent
K211109N1 TiUltra TCC Implant SystemDZESubstantially Equivalent
K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet TrayKCTSubstantially Equivalent

Registered establishments

FDA registered establishments for Nobel Biocare Services AG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30086936723008693672Nobel Biocare Services AGBalz Zimmermann-Strasse 7, Kloten Zurich CH-8302 CH2026and 5 more, listed in full below

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2828-2020NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.Class IITerminated

Verification record

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