FDA.reportPublic FDA data

ET Scan Healing Abutment

Primary DI
00810125998744
Brand
ET Scan Healing Abutment
Company
HIOSSEN, INC.
Model
ETSHA405RTH
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
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
K253372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253372000ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.2026-05-14NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810125998744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810125998744008101259987448101259987440810125998744

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Regulatory Flags#

DUNS number
796083090
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810125998713ET Scan Healing AbutmentETSHA404MTH2026-09-04
00810125998720ET Scan Healing AbutmentETSHA404RTH2026-09-04
00810125998737ET Scan Healing AbutmentETSHA405MTH2026-09-04
00810125998751ET Scan Healing AbutmentETSHA407MTH2026-09-04
00810125998768ET Scan Healing AbutmentETSHA407RTH2026-09-04
00810125998775ET Scan Healing AbutmentETSHA409MTH2026-09-04
00810125998782ET Scan Healing AbutmentETSHA409RTH2026-09-04
00810125998799ET Scan Healing AbutmentETSHA454MTH2026-09-04
00810125998805ET Scan Healing AbutmentETSHA454RTH2026-09-04
00810125998812ET Scan Healing AbutmentETSHA455MTH2026-09-04
00810125998829ET Scan Healing AbutmentETSHA455RTH2026-09-04
00810125998836ET Scan Healing AbutmentETSHA457MTH2026-09-04
00810125998843ET Scan Healing AbutmentETSHA457RTH2026-09-04
00810125998850ET Scan Healing AbutmentETSHA459MTH2026-09-04
00810125998867ET Scan Healing AbutmentETSHA459RTH2026-09-04
00810125998874ET Scan Healing AbutmentETSHA504RTH2026-09-04
00810125998881ET Scan Healing AbutmentETSHA505RTH2026-09-04
00810125998898ET Scan Healing AbutmentETSHA507RTH2026-09-04
00810125998904ET Scan Healing AbutmentETSHA509RTH2026-09-04
00810125998911ET Scan Healing AbutmentETSHA604RTH2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998751ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998775ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998805ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998812ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125999000EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04