FDA.reportPublic FDA data

KöR

Primary DI
00850362007137
Brand
KöR
Company
EVOLVE DENTAL TECHNOLOGIES, INC.
Model
KöR Dam
Catalog number
80-1032
Device description
Dental dam.
Published
2021-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIGRetractor, All Types

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850362007137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850362007137008503620071378503620071370850362007137

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, non-latexA sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005479970
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850362007052KöRKöR Desensitizer-10ml10-10102017-01-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622197Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622203Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622210Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622227Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622234Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622241Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622258Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622265Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622272Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622289Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
10304040196998Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197001Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197018Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
00348783010220Premier RetractorsPREMIER DENTAL PRODUCTS COMPANYEIG2026-05-06
G149NP260020NPSACME ENTERPRISE.EIG2026-05-01
G149NPORR0NPSACME ENTERPRISE.EIG2026-05-01
00371347023459Advance Dental ProductsThe Atlanta Dental Supply CompanyEIG2026-04-14
B382SD9144082080Surgical DirectSurgical Direct, Inc.EIG2026-02-12
B382SD9210921010Surgical DirectSurgical Direct, Inc.EIG2026-02-12
00841336128828Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIG2025-11-04
00190707191153Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
00190707191160Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
B382SD5615280Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640120Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640140Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640160Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640180Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640200Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640220Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640300Surgical DirectSurgical Direct, Inc.EIG2025-10-06