FDA.reportPublic FDA data

Simplant

Primary DI
07392532191237
Brand
Simplant
Company
DENTSPLY IH, INC.
Model
Version 18
Catalog number
54500277O18
Device description
Simplant OneShot
Published
2018-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172239000SIMPLANT 18Dentsply Sirona2018-04-04LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07392532191237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532191237073925321912377392532191237

GMDN Terms#

Term, Definition table
TermDefinition
Panoramic/tomographic dental x-ray system application softwareAn application or operating data program designed for use in, or together with a panoramic/tomographic dental x-ray system configuration. A basic set of applications programs and routines are included with any computer-controlled diagnostic imaging system. Some applications software routines or groups of routines (packages) must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)531-3481implants-na-cs@dentsplysirona.
+1(800)531-3481implants-na-cs@dentsplysirona.com

Regulatory Flags#

DUNS number
847337201
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07392532281730ATLANTIS®36020360202026-07-29
07392532281747ATLANTIS®36021360212026-07-29
07392532291685ATLANTIS®680219992026-01-21
07392532290688ATLANTIS®680219972026-01-21
07392532290695ATLANTIS®680219952026-01-21
07392532290701ATLANTIS®680219962026-01-21
07392532083433ATLANTIS®355022016-03-16
07392532083440ATLANTIS®355032016-03-16
07392532083457ATLANTIS®355042016-03-16
07392532083464ATLANTIS®355052016-03-16
07392532177088ATLANTIS®350202016-03-16
07392532177118ATLANTIS®353022016-03-16
07392532177125ATLANTIS®353042016-03-16
07392532177132ATLANTIS®353522016-03-16
07392532177149ATLANTIS®353532016-03-16
07392532177156ATLANTIS®353542016-03-16
07392532177163ATLANTIS®353552016-03-16
07392532177187ATLANTIS®354022016-03-16
07392532177194ATLANTIS®354042016-03-16
07392532274664DS680219992022-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01