FDA.reportPublic FDA data

Candid Redo Impression Kit

Primary DI
00850004223031
Brand
Candid Redo Impression Kit
Company
CANDID CARE CO.
Model
URBD0003
Device description
Redo Impression Kit (Large 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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K821221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821221000DENTAL IMPRESSION MATERIALCrown Delta Corp.1982-06-07ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004223031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004223031008500042230318500042230310850004223031

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108729170
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004223307CandidProFGS-00252026-09-04
00850004223413CandidProFGS-00262026-09-04
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
00850004223062Candid Redo Impression KitRDMDORANGE000012019-03-01
00850004223086Candid Redo Impression KitUBRD00022019-03-01
00850004223093Candid Redo Impression KitURBD00042019-03-01

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