FDA.reportPublic FDA data

IMPLANOVA

Primary DI
00858809005494
Brand
IMPLANOVA
Company
DENTAL EVOLUTIONS, INC
Model
AIMPRC
Published
2025-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858809005494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858809005494008588090054948588090054940858809005494

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
065079164
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858809005111IMPLANOVADHL2025-09-10
00858809005333IMPLANOVA20SRW2025-09-10
00858809005340IMPLANOVA80SRW2025-09-10
00858809005982IMPLANOVADHS2025-09-10
00858809005999IMPLANOVADHM2025-09-10
00860007860522IMPLANOVARDHS2025-09-10
00860007860539IMPLANOVARDHM2025-09-10
00860007860546IMPLANOVARDHM2025-09-10
00860009618060IMPLANOVA45FG2025-09-10
00858809005357ImplanovaABSCR2025-08-11
00858809005296IMPLANOVAAHTSS2025-08-21
00858809005302IMPLANOVAAHTSM2025-08-21
00858809005319IMPLANOVAAHTSL2025-08-21
00858809005449IMPLANOVAAIMPT2025-08-21
00858809005678IMPLANOVAAHBNPS2025-08-21
00858809005685IMPLANOVAAHBSS2025-08-21
00858809005692IMPLANOVAAHBSPS2025-08-21
00858809005708IMPLANOVAAHBNPM2025-08-21
00858809005715IMPLANOVAAHBNPL2025-08-21
00858809005722IMPLANOVAAHBSPM2025-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D1254104Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254114Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254124Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254134Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254144Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254154Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254164Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254184Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254194Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254204Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254304Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
08961104622654Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08961104622661Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08906139322087Taglus Impression TrayLAXMI DENTAL LIMITEDEHY2026-01-09
00190707193195Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
00190707193201Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
00190707110789DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110796DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110802DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110819DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110826DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110833DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110840DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110857DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110864DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110871DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110888DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110895DuraLock®Ortho Organizers, Inc.EHY2025-09-25
07615208301304Centric TrayIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHY2025-03-20