FDA.reportPublic FDA data

Rapid Arch Large Tapered Upper 1PK, Shade B1

Primary DI
D990RALTU1PKB10
Brand
Rapid Arch Large Tapered Upper 1PK, Shade B1
Company
SMART DENTURE CONVERSIONS, LLC
Model
RA-LTU1PK-B1
Published
2024-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
D990RALTU1PKB10PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8555500707contact@smartdentureconversions.com

Regulatory Flags#

DUNS number
010613514
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D990SADCK1PK0Single Arch Dam Conversion Kit 1PKSADCK1PK2025-06-30
D990AD0Access Drill 1PKAD2022-12-26
D990BHHDPS10PK0Prosthetic Screw 10PK, BioHorizonsBHHD-PS10PK2022-12-26
D990BHHDPSK0Premium Starter Kit, BioHorizonsBHHD-PSK2022-12-26
D990BHHDRK0Recharge Kit, BioHorizonsBHHD-RK2022-12-26
D990BHHDSFA10PKDK0Separable Fastener Assembly 10PK w Drill Kit, BioHorizonsBHHD-SFA10PKDK2022-12-26
D990BHHDSK0Starter Kit, BioHorizonsBHHD-SK2022-12-26
D990CM10PK0Coating Mandrel 10PKCM10PK2022-12-26
D990CM6PK0Coating Mandrel 6PKCM6PK2022-12-26
D990COD0Clean Out Drill 1PKCOD2022-12-26
D990DK0Drill Kit 1PKDK2022-12-26
D990KDIHCM10PK0Coating Mandrel 10 Pack, Paltop (IHEX)KDIH-CM10PK2022-12-26
D990KDIHCM6PK0Coating Mandrel 6PK, Paltop (IHex)KDIH-CM6PK2022-12-26
D990KDIHLA10PK0Lab Analog 10PK, Paltop (IHex)KDIH-LA10PK2022-12-26
D990KDIHLTD0Torque Driver 1PK, Paltop (IHex)KDIH-LTD2022-12-26
D990KDIHPS10PK0Prosthetic Screw 10PK, Paltop (IHex)KDIH-PS10PK2022-12-26
D990KDIHPSK0Premium Starter Kit, Paltop (IHex)KDIH-PSK2022-12-26
D990KDIHRK0Recharge Kit, Paltop (IHex)KDIH-RK2022-12-26
D990KDIHSFA10PKDK0Separable Fastener Assembly 10PK - Drill Kit Included, Paltop (IHex)KDIH-SFA10PKDK2022-12-26
D990KDIHSK0Starter Kit, Paltop (IHex)KDIH-SK2022-12-26

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