FDA.reportPublic FDA data

Sherlock

Primary DI
D86349300
Brand
Sherlock
Company
Open Implants, LLC
Model
4930
Device description
Nobel Active NP Multi-Unit Abutment H3 Uniblock
Published
2021-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193335000SherlockOpen Implants, LLC2020-03-24NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D86349300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
107098053
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D86336430Sherlock364336432017-05-30
D86336440Sherlock364436442017-05-30
D86336450Sherlock364536452017-05-30
D86336460Sherlock364636462017-05-30
D86336470Sherlock364736472017-05-30
D86336480Sherlock364836482017-05-30
D86336520Sherlock365236522017-05-30
D86336530Sherlock365336532017-05-30
D86336560Sherlock365636562017-05-30
D86336570Sherlock365736572017-05-30
D86336610Sherlock366136612017-05-30
D86336620Sherlock366236622017-05-30
D86336630Sherlock366336632017-05-30
D86336640Sherlock366436642017-05-30
D86336650Sherlock366536652017-05-30
D86339150Sherlock391539152017-05-30
D86349440Sherlock49442021-02-18
D86353280Sherlock53282021-02-18
D86335932Sherlock35932021-02-18
D86335942Sherlock35942021-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046888EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046895EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046901EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046918EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046925EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046932EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046949EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046970EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046987EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046994EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047007EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047014EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
08809917132710Healing Abutment SystemOsstem Implant Co., Ltd.NHA2026-07-29
08800070223673Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223710Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223758Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223796Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27