FDA.reportPublic FDA data

KöR

Primary DI
00850362007052
Brand
KöR
Company
EVOLVE DENTAL TECHNOLOGIES, INC.
Model
KöR Desensitizer-10ml
Catalog number
10-1010
Device description
KöR Desensitizer-10ml
Published
2017-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953405000HEMA-BENZHealth-Dent Intl., Inc.1995-09-27KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850362007052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850362007052008503620070528503620070520850362007052

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store above 77°F (25°C). Refrigeration is recommended if not used for a long period of time. Allow to return to room temperature prior to use. DO NOT FREEZE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949 7130909lfjastad@evolvedental.com

Regulatory Flags#

DUNS number
005479970
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850362007137KöRKöR Dam80-10322021-05-18
00850362007113KöRKöR Retractor & Suction Tip (Max)80-10062021-03-31
00850362007120KöRKöR Retractor & Suction Tip (Ulra)80-10132021-03-31
00850362007144KöRKöR Suction Tip80-10292021-03-31
00850362007151KöRKöR Retractor (Blue) - Medium80-10592021-03-31
00850362007168KöRKöR Retractor (Green) - Small80-10602021-03-31
00850362007175KöRKöR Retractor (Red) - Large80-10612021-03-31
00850362007021KöRKöR Impression Tray Adhesive10-10082019-03-15
00850362007069KöRKöR Teeth Desensitizer - 2.5ml10-10112017-01-23
00850362007076KöRKöR Teeth Desensitizer - 5ml10-10122017-01-23
00850362007083KöRKöR Complete Desensitizer - 5mL10-10172017-03-06
00850362007090KöRKöR Complete Desensitizer - 3mL10-10162017-03-06
00850362007106KöRKöR Complete Desensitizer - 10mL10-10182017-03-06
00850362007007KöRKöR Putty - Fast Set10-10132017-03-10
00850362007014KöRKöR Putty - Regular Set10-10142017-03-10
00850362007038KöRKöR Light Body Wash10-10152017-03-10
00850362007045KöRKöR Heavy Body Base10-10042017-03-10

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J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
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D0019064150LucitoneDentsply International Inc.KLE2025-07-01
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D0019064170LucitoneDentsply International Inc.KLE2025-07-01
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D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
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07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
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