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 AB

GOTEBORG Vastra Gotaland, SE

NOBEL BIOCARE AB appears in FDA device records in GOTEBORG Vastra Gotaland, SE. FDA records list 95 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
95
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

Showing 50 of 95

FDA records hold 95 510(k) clearances for Nobel Biocare AB between 2002 and 2026. The busiest year on record is 2006, with 11. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Nobel Biocare AB, by decision year
YearClearances
20021
20032
20045
20054
200611
20079
20082
20097
20104
20112
20133
20142
20151
20169
20179
20186
20193
20205
20211
20221
20233
20241
20252
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNHASubstantially Equivalent
K252197Nobel Biocare S Series ImplantsDZESubstantially Equivalent
K243834NobelZygoma TiUltra Implant systemDZESubstantially Equivalent
K240346NobelProcera Zirconia Implant BridgeNHASubstantially Equivalent
K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNHASubstantially Equivalent
K231898DTX Studio Clinic (4.0)LLZSubstantially Equivalent
K223677Titanium Abutment Blank Nobel Biocare N1 TCCNHASubstantially Equivalent
K221921DTX Studio Clinic 3.0MYNSubstantially Equivalent
K213562DTX Studio Clinic 3.0LLZSubstantially Equivalent
K212125Nobel Biocare Dental Implant Systems Portfolio - MR ConditionalDZESubstantially Equivalent
K202452NobelProcera Zirconia Implant BridgeNHASubstantially Equivalent
K203156DTX Studio ClinicLLZSubstantially Equivalent
K202344TiUltra Implants and Xeal AbutmentsDZESubstantially Equivalent
K200810IPS CaseDesignerLLZSubstantially Equivalent
K200040Universal Base Conical Connection (CC)NHASubstantially Equivalent
K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet PlateKCTSubstantially Equivalent
K181932DTX Studio designPNPSubstantially Equivalent
K173418NobelParallel Conical ConnectionDZESubstantially Equivalent
K181869On1 Universal AbutmentNHASubstantially Equivalent
K183069NobelZygoma 0°DZESubstantially Equivalent
K180899Universal Base AbutmentNHASubstantially Equivalent
K181075PureSet TrayKCTSubstantially Equivalent
K163600Kit Boxes and Kit PlatesKCTSubstantially Equivalent
K172224DTX Studio diagnoseLLZSubstantially Equivalent
K172854NobelPerfect AbutmentsNHASubstantially Equivalent
K171466NobelDesign, DTX Studio DesignNHASubstantially Equivalent
K171142Healing Cap Multi-Unit TitaniumNHASubstantially Equivalent
K172352TREFOIL SystemDZESubstantially Equivalent
K170135TREFOIL SystemDZESubstantially Equivalent
K161416Multi-unit Abutment PlusNHASubstantially Equivalent
K161598NobelZygoma 0°DZESubstantially Equivalent
K161655On1 ConceptNHASubstantially Equivalent
K163122NobelClinician, DTX Studio implantLLZSubstantially Equivalent
K162043NobelProcera HT ML FCZ BridgeELLSubstantially Equivalent
K161435Temporary Snap AbutmentNHASubstantially Equivalent
K161634IPS CaseDesignerLLZSubstantially Equivalent
K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNHASubstantially Equivalent
K153534NobelProcera HT ML Full Contour Zirconia CrownELLSubstantially Equivalent
K160119NobelSpeedy GroovyDZESubstantially Equivalent
K153036NobelDesign SoftwareNHASubstantially Equivalent
K152836TREFOIL SystemDZESubstantially Equivalent
K152093NobelZygoma 45°DZESubstantially Equivalent
K142260NobelActiveDZESubstantially Equivalent
K133731NOBELACTIVE WIDE PLATFORM (WP)DZESubstantially Equivalent
K133377NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACENHASubstantially Equivalent
K120954NOBELPROCERA PEEK ABUTMENTSNHASubstantially Equivalent
K123976NOBELCLINICIANLLZSubstantially Equivalent
K122602NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMSNHASubstantially Equivalent
K112259NOBELACTIVE 3.0 GOLDADAPT ABUTMENTSNHASubstantially Equivalent
K11158115 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVENHASubstantially Equivalent

Registered establishments

FDA registered establishments for Nobel Biocare AB, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96119923002807692NOBEL BIOCARE ABBox 5190, SE-402 26, GOTEBORG Vastra Gotaland 411 17 SE2026and 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-1101-2025. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing functionDue to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.Class IIOpen, Classified
Z-1565-2022Nobel Biocare N1 TiUltra TCC NP 3.5x13mmDue to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.Class IIOpen, Classified

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