FDA.reportPublic FDA data

RS Try-In

Primary DI
04260635980542
Brand
RS Try-In
Company
DeltaMed GmbH
Model
RS001535
Catalog number
RS001535
Device description
RS Try-In 1000g
Published
2022-02-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EEAPlate, Base, Shellac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEAPlate, Base, ShellacDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260635980542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260635980542042606359805424260635980542

GMDN Terms#

Term, Definition table
TermDefinition
Dental base plateA foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00avoid direct sunlight
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344805101
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDEL6051070Insure® Lite6051076051072023-06-12
EDEL6021080Insure® 6021086021082023-06-05
04260635980481RS Surgical GuideRS001533RS0015332022-02-11
04260635981556PRO Resins Guide X019.3054019.30542026-01-26
EDEL6021010Insure® 6021016021012023-06-05
EDEL6021050Insure® 6021056021052023-06-05
04260635981570RS VIVO GuideRS006196RS0061962025-11-24
EDEL160526003Delta Guide XT160526016052602025-11-24
EDEL6051010Insure® Lite6051016051012023-06-05
EDEL6051020Insure® Lite6051026051022023-06-12
EDEL605ACL0Insure® Lite Automix605ACL605ACL2023-06-12
EDEL6021020Insure® 6021026021022023-06-05
EDEL160511003Delta Splint160511016051102022-02-11
EDEL160524003Delta Guide S160524016052402022-02-11
EDEL162112003Delta Try-In162112016211202022-01-31
04260635981587RS VIVO TrayRS006198RS0061982025-07-29
04260635981594RS VIVO Try-InRS006199RS0061992025-07-29
EDEL162112103Delta Try-In XT162112116211212025-07-29
EDEL162162003Delta Tray Rose162162016216202025-07-29
04260635981600RS VIVO C&B UltimateRS006202RS0062022025-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412328068Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328075Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328082Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328099Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328105Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
E239D359501FotoDent® TryInDreve Dentamid GmbHEEA2026-02-27
04260635981594RS VIVO Try-InDeltaMed GmbHEEA2025-07-29
EDEL162112103Delta Try-In XTDeltaMed GmbHEEA2025-07-29
EPRC0220003ACRY PRINT RU-003 Try-Inpro3dure medical GmbHEEA2025-03-31
EPRC768485UCAN Print Try-Inpro3dure medical GmbHEEA2025-03-31
D161280200Axio-BaseAxiodent Inc.EEA2024-10-02
08720604633832Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
08720604633849Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
08720604633856Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
D040711820Veri DENT TryinWHIP-MIX CORPORATIONEEA2024-04-18
EPRCD1001651printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
EPRCD1001652printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
EPRCD1001653printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
00860010425411LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
00860010425428LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
00860010425435LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
D967130010Hiflex Base PlatesPREVEST DENPRO LIMITEDEEA2022-12-19
EPRCD1001602PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-09-12
EPRCD1001603PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-09-12
EPRCD1001601PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-08-17
10850039704151Try-In 2Sprintray, Inc.EEA2022-02-28
04260635980207P pro Try-InDeltaMed GmbHEEA2022-02-11
EDEL162111003Delta Try-InDeltaMed GmbHEEA2022-02-11
EDEL162112003Delta Try-InDeltaMed GmbHEEA2022-01-31
E22160491V-Print Try-InVOCO GmbHEEA2020-06-16