FDA.reportPublic FDA data

Plastcare

Primary DI
D915RIT73132
Brand
Plastcare
Company
Plastcare USA
Model
RIT-7313
Device description
Dental Impression Bite Tray Quadrant (Yellow)
Published
2020-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D915RIT73132PackageHIBCC20In Commercial Distribution
D915RIT73131PrimaryHIBCC0
D915RIT73130Unit of UseHIBCC0

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

Regulatory Flags#

DUNS number
079299604
Device count
35
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
D915MBK21SentinelMBK22019-12-12
D915MBL21SentinelMBL22019-12-12
D915MPI21SentinelMPI22019-12-12
D915MWH21SentinelMWH22019-12-12
D915WHW1PlastcareWHW2020-05-01
D915WHW2PlastcareWHW2020-05-01
D915MBK22SentinelMBK22019-12-12
D915MBL22SentinelMBL22019-12-12
D915MPI22SentinelMPI22019-12-12
D915MWH22SentinelMWH22019-12-12
D915RIT50101PlastcareRIT-50102020-03-11
D915RIT50151PlastcareRIT-50152020-03-11
D915RIT50201PlastcareRIT-50202020-03-11
D915RIT50251PlastcareRIT-50252020-03-11
D915RIT50152PlastcareRIT-50152020-03-11
D915RIT50202PlastcareRIT-50202020-03-11
D915RIT50252PlastcareRIT-50252020-03-11
D915RIT50102PlastcareRIT-50102020-03-11
D915CLB1PlastcareCLB2020-03-10
D915K21061VergeK21062020-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412313088Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412313095Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320192Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320222Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320413Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320420Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06909412320437Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679033Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679040Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679057Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679064Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679309Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
06970402679927Light Curing TraySHANDONG HUGE DENTAL MATERIAL CORPORATIONEBH2026-10-26
08800017902395Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902401Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902418Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902425Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902432Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
D14307560147448590Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBH2026-07-23
00840456224427JMUJMU DENTAL, INCEBH2026-07-20
00840456224434JMUJMU DENTAL, INCEBH2026-07-20
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09