FDA.reportPublic FDA data

The Essentials By 3D Dental

Primary DI
00810126503145
Brand
The Essentials By 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
IMSL6
Catalog number
IMSL6
Device description
Impression Trays Perforated #6 Small Lower Dozen
Published
2023-02-28
Public version status
Update
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
10810126503142PackageGS110In Commercial Distribution
00810126503145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081012650314210810126503142
00810126503145008101265031458101265031450810126503145

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080194935
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126508362Essentials By 3D DentalGN300-L2026-04-16
008101265062213D DentalRCPC2026-03-24
00810126506757Comfortox5CC30132026-03-24
00810126506764Comfortox5CC2982026-03-24
00810126508355Basik by 3D DentalBPGLA4672026-03-17
00810126508331Basik by 3D DentalBPGC9422026-03-17
00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
00810126506054The Essentials By 3D DentalPL-HCSPL-HCS2023-02-28
00810126506061The Essentials By 3D DentalPL-HRLGPL-HRLG2023-02-28
008171690201723D Dental - DreamDFVBG2016-12-12
008171690201893D Dental - DreamDFVSM2016-12-12
008171690214763D Dental-DreamDFVCM2017-12-04
008171690219643D Dental- BiovivaBHG2018-08-30
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D12518N4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4022Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4042Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4052Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518S4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518S4022Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518S4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518T4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518T4022Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518T4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254334Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254344Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254354Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254364Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254374Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254384Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254394Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254404Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254514Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254524Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254534Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254544Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254554Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254564Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254574Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254584Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254594Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254604Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D125N4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09