FDA.reportPublic FDA data

ThermTray1 Anterior

Primary DI
10859787002106
Brand
ThermTray1 Anterior
Company
ADVANTAGE DENTAL PRODUCTS INC
Model
120
Device description
Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials.
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
10859787002106PackageGS110In Commercial Distribution
00859787002109PrimaryGS10
00859787002192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085978700210610859787002106
00859787002109008597870021098597870021090859787002109
00859787002192008597870021928597870021920859787002192

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit125 Degrees Fahrenheit
Special Storage Condition, Specify00Use in well ventilated area. Store in cool, dry place protected from humidity. Do not store with acids and alkalis
Storage Environment Temperature0 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248-391-1625contact@advantagedentalinc.com

Regulatory Flags#

DUNS number
607859147
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00859787002062ThermTray1 Quadrant UL-LR 1122016-11-04
00859787002079ThermTray1 Quadrant UR-LL1142016-11-04
00859787002086TherTray1 3/4/-Arch UL-LR1162016-11-04
00859787002093ThermTray1 3/4/-Arch UR-LL1182016-11-04
00859787002109ThermTray1 Anterior1202016-11-04
00859787002017MatrixTemp Temporary Crown and Bridge Material1012016-10-21
00859787002024MatrixTemp Temporary Crown and Bridge Material1022016-10-21
00859787002031MatrixTemp Temporary Crown and Bridge Materail1032016-10-21
00859787002000Hemaseal & Cide 1702016-09-16
00859787002048Hemaseal & Cide - Unidose1802016-09-16
10859787002007Hemaseal & Cide 1702016-09-16
10859787002045Hemaseal & Cide - Unidose1802016-09-16
00859787002055Temporary Crown Matrix Buttons1002016-10-21
10859787002014MatrixTemp Temporary Crown and Bridge Material1012016-10-21
10859787002021MatrixTemp Temporary Crown and Bridge Material1022016-10-21
10859787002038MatrixTemp Temporary Crown and Bridge Materail1032016-10-21
10859787002052Temporary Crown Matrix Buttons1002016-10-21
10859787002069ThermTray1 Quadrant UL-LR 1122016-11-04
10859787002076ThermTray1 Quadrant UR-LL1142016-11-04
10859787002083TherTray1 3/4/-Arch UL-LR1162016-11-04

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