FDA.reportPublic FDA data

Candid Redo Impression Kit

Primary DI
00850004223062
Brand
Candid Redo Impression Kit
Company
CANDID CARE CO.
Model
RDMDORANGE00001
Device description
Candid redo impression (medium trays)
Published
2019-03-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed
EIGRetractor, All Types
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1
EIGRetractor, All TypesDental1
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004223062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004223062008500042230628500042230620850004223062

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
9177542056dan.michaeli@candidco.com

Regulatory Flags#

DUNS number
108729170
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00850004223253CandidProFGS-00022026-07-27
00850004223260CandidProFGS-00042026-07-27
00850004223314ProMonitoringFGS-20022026-07-27
00850004223338ProMonitoringFGS-20032026-07-27
00850004223352ProMonitoringFGS-20082026-07-27
00850004223383OlivFGS-30042026-07-27
00850004223390OlivFGS-30082026-07-27
00850004223550CandidProFGS-00082026-07-27
00850004223345Candid Impression KitFGS-00102021-10-07
00850004223987Candid Refinement Impression KitITISK000012021-03-31
00850004223024Candid Impression KitIKHELLO000012020-07-20
00850004223147Candid Redo Impression KitRDKETTM00012019-10-04
00850004223017Candid Impression KitIKFINISHED000022019-03-01
00850004223048Candid Redo Impression KitRDSMORANGE000012019-03-01
00850004223055Candid Redo Impression KitRDMDPAT000012019-03-01
00850004223086Candid Redo Impression KitUBRD00022019-03-01
00850004223093Candid Redo Impression KitURBD00042019-03-01
00850004223321PermaForm RetainerFGS-00032025-11-06
00850004223376Oliv AlignerFGS-30022025-11-06
00850004223789Candid Impression KitFGS-00092021-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858466005608POLYTRACTORDENTAMERICA, INC.EIG2026-07-27
00190776405946MillenniumAvalign Technologies, Inc.EIG2026-07-26
00190776405762MillenniumAvalign Technologies, Inc.EIG2026-07-24
00190776405793MillenniumAvalign Technologies, Inc.EIG2026-07-24
00304040194416Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194423Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194430Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194447Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
07506338322638VIVID JELMDC DENTALELW2026-07-20
07506338322645VIVID JELMDC DENTALELW2026-07-20
07506338322652VIVID JELMDC DENTALELW2026-07-20
07506338322669BLU JELMDC DENTALELW2026-07-20
07506338322676BLU JELMDC DENTALELW2026-07-20
07506338322690VIVID JELMDC DENTALELW2026-07-20
00190776403225MillenniumAvalign Technologies, Inc.EIG2026-07-19
00190776395599MillenniumAvalign Technologies, Inc.EIG2026-07-14
00840456218907JMUJMU DENTAL, INCEHY2026-07-09
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
00840456223321JMUJMU DENTAL, INCEIG2026-07-07