FDA.reportPublic FDA data

Candid Impression Kit

Primary DI
00850004223024
Brand
Candid Impression Kit
Company
CANDID CARE CO.
Model
IKHELLO00001
Device description
August 2020 Promo
Published
2020-07-20
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
JESFloss, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1
EIGRetractor, All TypesDental1
ELWMaterial, ImpressionDental2
JESFloss, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082560000PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACTKettenbach GmbH & Co. KG2008-09-08ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004223024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004223024008500042230248500042230240850004223024

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

Contacts#

Phone, Email table
PhoneEmail
917-754-2056dan.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
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
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
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
00850004223321PermaForm RetainerFGS-00032025-11-06

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