Product Code: NHA


Products Classified as NHA

1338Abutment, Implant, Dental, EndosseousEndosseous Dental Implant Abutment.

Total Product Life Cycle (TPLC) Devices

1338Abutment, Implant, Dental, EndosseousEndosseous Dental Implant Abutment.

FDA Consensus Standards

Abutment, Implant, Dental, Endosseous [35632]21 CFR §872.3630 🔎
Abutment, Implant, Dental, Endosseous [36822]21 CFR §872.3630 🔎
Abutment, Implant, Dental, Endosseous [31733]21 CFR §872.3630 🔎

Pre-market Notifications for NHA

K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG
K192522TSV BellaTek Express And BellaTek Flex AbutmentsBiomet 3i LLC
K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S
K192436Healing Abutments And Cover ScrewsDentium Co., Ltd.
K192229Neodent Implant System- GM Titanium Base For BridgeJJGC Industria E Comercio De Materiais Dentarios S.A.
K192029Straumann PUREloc AbutmentsInstitut Straumann AG
K191986DESS Dental Smart SolutionsTerrats Medical SL
K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S
K191634Scan Abutments And Comfort CapsDentium Co., Ltd.
K191382IPS E.max CAD Abutment Solutions- Extra SystemsIvoclar Vivadent, AG
K191250Southern Implants PEEK AbutmentsSouthern Implants (Pty) Ltd
K191222Inclusive Titanium Abutments Compatible With: Dentsply Implants Astra Tech Implant System EVPrismatik Dentalcraft, Inc.
K191191Neodent Implant System - Temporary AbutmentsJJGC Industria E Comercio De Materiais Dentarios S.A.
K191123Multi-unit AbutmentsMedentika GmbH
K190654Straumann CI RD Ceramic Healing CapsInstitut Straumann AG

Global Unique Device Identification Database

00614985000879ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008087ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008070ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008063ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008056ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008049ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008032ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008025ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008018ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950008001ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950007998ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950007080ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950007042ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950007035ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
00614950007028ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Maude Adverse Events

LEGACY STRAIGHT ABUTMENTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY STRAIGHT ABUTMENTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY ANGLED ABUTMENTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY STRAIGHT CONTOURED ABUTMENTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
BELLATEK? ZIRCONIA ABUTMENTBIOMET 3I2019-11-27
CERTAIN? TITANIUM HEXED SCREWBIOMET 3I2019-11-27
HEALING COLLARZIMMER DENTAL2019-11-27
HEAL COLLAR 3.5X4.5, 3MMZIMMER DENTAL2019-11-26
ABUTMENT SCREWBIOMET 3I2019-11-26
CERTAIN? TITANIUM HEXED SCREWBIOMET 3I2019-11-26
CERTAIN? TITANIUM HEXED SCREWBIOMET 3I2019-11-26
UNKNOWN 3I ABUTMENT SCREWBIOMET 3I2019-11-25
EP? HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)BIOMET 3I2019-11-22
UNK HEALING ABUTMENTZIMMER DENTAL2019-11-22
HEAL COLLAR 3.5X4.5, 5MMZIMMER DENTAL2019-11-22
HEAL COLLAR 3.5X4.5, 5MMZIMMER DENTAL2019-11-22
HEAL COLLAR 3.5X4.5, 3MMZIMMER DENTAL2019-11-22
HEAL COLLAR 3.5X4.5, 3MMZIMMER DENTAL2019-11-22
HEAL COLLAR 3.5X5.5, 5MMZIMMER DENTAL2019-11-21
TITANIUM HEXED UNISCREWBIOMET 3I2019-11-20
SCREWZIMMER DENTAL2019-11-19
SCREWBIOMET 3I2019-11-19
SCREWBIOMET 3I2019-11-19
SCREWBIOMET 3I2019-11-15
SCREWBIOMET 3I2019-11-15
CERTAIN? GOLD-TITE? HEXED SCREWBIOMET 3I2019-11-14
SCREWBIOMET 3I2019-11-14
SCREWBIOMET 3I2019-11-14
SCREWBIOMET 3I2019-11-14
INTERACTIVE HEALING COLLAR NARROWIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-14
HEAL COLLAR 3.5X5.5, 5MMZIMMER DENTAL2019-11-13
UNK LZ HEALING CAPZIMMER DENTAL2019-11-08
INTERACTIVE HEALING COLLARIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-08
CERTAIN? LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)BIOMET 3I2019-11-08
HEAL COLLAR 4.5X4.5, 5MMZIMMER DENTAL2019-11-08
CERTAIN? STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H)BIOMET 3I2019-11-07
GOLD-TITE? SQUARE UNISCREWBIOMET 3I2019-11-07
CERTAIN? BELLATEK? ENCODE? HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)BIOMET 3I2019-11-07
CERTAIN? GOLD-TITE? HEXED SCREWBIOMET 3I2019-11-06
UNKNOWN BIOMET SCREWBIOMET 3I2019-11-01
15 DEG TAPER,3.5P 2MM-3MMZIMMER DENTAL2019-10-31
GOLD-TITE? SQUARE UNISCREWBIOMET 3I2019-10-31
TITANIUM SQUARE UNISCREWBIOMET 3I2019-10-31
TITANIUM HEXED UNISCREWBIOMET 3I2019-10-31
GOLD-TITE? SQUARE UNISCREWBIOMET 3I2019-10-31
GOLD-TITE? HEXED UNISCREWBIOMET 3I2019-10-31
CERTAIN? GOLD-TITE? HEXED SCREWBIOMET 3I2019-10-31
CERTAIN? TITANIUM HEXED SCREWBIOMET 3I2019-10-31
CERTAIN? GOLD-TITE? HEXED SCREWBIOMET 3I2019-10-30
CERTAIN? GOLD-TITE? HEXED SCREWBIOMET 3I2019-10-30

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.