FDA.reportPublic FDA data

Temp Esthetic

Primary DI
D87030071201
Brand
Temp Esthetic
Company
Harvest Dental Products, LLC
Model
30071-20
Device description
Temp Esthetic Disc, 95 X 20mm, Shade C1
Published
2021-05-14
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
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102341000VIPI BLOCKVipi Industria,Comercio,Exportacao E Importacao DE2010-12-16EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D87030071201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7146747400hello@harvestdental.com

Regulatory Flags#

DUNS number
794668751
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D87097961Harvest EasyGum979697962026-01-20
D87097941Harvest EasyGum979497942026-01-05
D87010035161Harvest Esthetic DCL Denture10035-1610035-162025-10-27
D87010035201Harvest Esthetic DCL Denture10035-2010035-202025-10-27
D87010035251Harvest Esthetic DCL Denture10035-2510035-252025-10-27
D870980011EasyGum Strip 980098002024-10-03
D87098401EasyGum Strip - Modifier984098402024-09-10
D87098421EasyGum Strip - Modifier984298422024-09-10
D87098441EasyGum Strip - Modifier984498442024-09-10
D87098461EasyGum Strip - Modifier984698462024-09-10
D87098481EasyGum Strip - Modifier984898482024-09-10
D87098501EasyGum Strip - Modifier985098502024-09-10
D87098521EasyGum Strip - Modifier985298522024-09-10
D87098541EasyGum Strip - Modifier985498522024-09-10
D87098561EasyGum Strip - Modifier985698562024-09-10
D87098581EasyGum Strip - Modifier985898582024-09-10
D87098601EasyGum Strip - Modifier986098602024-09-10
D87097972EasyGum Strip979797972024-07-23
D870980426EasyGum Strip980498042024-07-23
D870980628EasyGum Strip980698062024-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762377FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762476FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774387FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774479FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774578FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774769FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774950FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774967FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774981FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775056FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775155FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775179FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775230FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775247FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775339FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775438FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28