FDA.reportPublic FDA data

Candid Redo Impression Kit

Primary DI
00850004223147
Brand
Candid Redo Impression Kit
Company
CANDID CARE CO.
Model
RDKETTM0001
Device description
Redo Impression Kit (Medium Trays) Kett Putty Digital
Published
2019-10-04
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

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
00850004223147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004223147008500042231478500042231470850004223147

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
Handling Environment Temperature00

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
true
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
00850004223017Candid Impression KitIKFINISHED000022019-03-01
00850004223048Candid Redo Impression KitRDSMORANGE000012019-03-01
00850004223055Candid Redo Impression KitRDMDPAT000012019-03-01
00850004223062Candid Redo Impression KitRDMDORANGE000012019-03-01
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
00190776426491MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426514MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426521MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426538MillenniumAvalign Technologies, Inc.EIG2026-08-18
G8791030240DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103024L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030260DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030380DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791031820DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791031830DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791048560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791062470DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791062480DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879KLB25060DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879KLB36110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879KLB40110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB30100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB35140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB4013DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879OBG30100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879OBG42110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879OBG70140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879WRL450DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879WRS350DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879ZYGOR180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
00858466005608POLYTRACTORDENTAMERICA, INC.EIG2026-07-27