FDA.reportPublic FDA data

IMPLANOVA

Primary DI
00860009618060
Brand
IMPLANOVA
Company
DENTAL EVOLUTIONS, INC
Model
45FG
Published
2025-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009618060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009618060008600096180608600096180600860009618060

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.

Regulatory Flags#

DUNS number
065079164
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
00858809005357ImplanovaABSCR2025-08-11
00858809005296IMPLANOVAAHTSS2025-08-21
00858809005302IMPLANOVAAHTSM2025-08-21
00858809005319IMPLANOVAAHTSL2025-08-21
00858809005449IMPLANOVAAIMPT2025-08-21
00858809005494IMPLANOVAAIMPRC2025-08-21
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
05712821017123Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017130Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017147Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017154Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017161Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017178Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017185Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017192Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017208Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017215Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017222Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017239Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017246Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017253Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017260Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017277Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017284Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017291Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017307Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017321Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017338Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017345Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA0Omnibut, Hiossen Regular, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA140Omnibut, Hiossen Regular, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025MGAOA0Omnibut, MegaGen AnyRidge, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025MGAOA140Omnibut, MegaGen AnyRidge, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26