510(k) clearances

Universal 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 Screw

Nobel Biocare AB · Dental

K253999Substantially EquivalentTraditionalNHA
Open FDA's page for this record
Third party flag
N
City
Goteborg
Advisory committee description
Dental
Address 1
Vastra Hamngatan 1
Statement or summary
Summary
Product code
NHA
Zip code
SE 411 17
Applicant
Nobel Biocare AB
Decision date
2026-08-06
Decision code
SESE
Country code
SE
Advisory committee
DE
Contact
Bernice Jim
K number
K253999
Date received
2025-12-15
Review advisory committee
DE
Postal code
SE 411 17
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

Universal 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 Screw

Harmonized identifiers (openFDA)
Device name
Abutment, Implant, Dental, Endosseous
Medical specialty description
Dental
Regulation number
872.3630
Device class
2
Registration number
3011936113, 3004748290, 3001082453, 2245590, 3004201263, 3013111692, 2029275, 3038715999, 1531062, 2032098, 3013551048, 3007518363, 3006592743, 3008517893, 3015775866, 8020776, 9613283, 9611993, 3004883837, 3011587077, 3019252621, 3014270094, 3015160953, 1424785, 3039641923, 3031462380, 3038549074, 2024024, 3008088588, 3014596751, 3027595870, 3011656326, 9680605, 8010591, 3013950969, 9611992, 1222315, 3012205930, 3004884150, 1000625496 +342 more
FEI number
3011936113, 3004748290, 3001082453, 3002807692, 2245590, 3004201263, 3013111692, 4838, 3038715999, 3013551048, 3007518363, 3006592743, 3008517893, 3015775866, 3003110073, 3004883837, 3002806651, 3011587077, 3019252621, 3014270094, 3003267134, 3015160953, 3039641923, 3031462380, 3038549074, 3000215273, 2024024, 3008088588, 3014596751, 3027595870, 3003719498, 3011656326, 3002808636, 3013950969, 3012205930, 3004884150, 2921595, 3013465593, 3005674514, 3002807009 +342 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.