FDA.reportPublic FDA data

EOS

Primary DI
04712568360415
Brand
EOS
Company
NORTH EOS INDUSTRIES INC.
Model
DentSpec -SMALL
Device description
EOS DENTAL MOUTH RETRACTOR -SMALL
Published
2018-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712568360415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712568360415047125683604154712568360415

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, single-useA hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656812989
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712568360873EOSEosProbe2018-11-30
04712568360514EOSEosCurette-RING BLUE2018-08-10
04712568360521EOSEosCurette- SPOON GREEN2018-08-10
04712568360361EOSEosSuction2018-08-10
04712568360385EOSEyelidSpec2018-08-10
04712568360538EOSEosOtoSpec I - 4.5MM (Keeler)2018-08-15
04712568360545EOSEosOtoSpec I-3.5MM (Keeler)2018-08-15
04712568360552EOSEosOtoSpec I -2.5MM (Keeler)2018-08-15
04712568360569EOSEosOtoSpec I -5.5mm (Keeler)2018-08-15
04712568360583EOSEosOtoSpec II -4.25MM (WA)2018-08-15
04712568360590EOSEosOtoSpec II -2.75MM (WA)2018-08-15
04712568360781EOSEosOtoSpec III-2.5MM, LARGER(HEINE)2018-08-15
04712568360798EOSEosOtoSpec III-4.0MM,LARGER (HEINE)2018-08-15
04712568360804EOSEosOtoSpec III -(LOCK)2.5MM SMALLER (HEINE)2018-08-15
04712568360811EOSEosOtoSpec III (LOCK)-4.0MM SMALLER (HEINE)2018-08-15
04712568360828EOSEosOtoSpec IV- Veterinary 4MM2018-08-15
04712568360835EOSEosOtoSpec IV-Veterinary 6MM (HEINE)2018-08-15
04712568360842EOSEosOtoSpec IV-Veterinary 9MM (HEINE)2018-08-15
04712568360859EOSEosOtoSpec IV-GUTTER-VET. 4MM(HEINE)2018-08-15
04712568360866EOSEosOtoSpec IV-GUTTER-VET. 6MM(HEINE)2018-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
D248938521Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
D2486054610Spandex Advanced Junior (Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
D2486054620Spandex Advanced Large ( Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603672Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603689Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-UseArmor Dental Corp.EIF2025-05-12
08800099963765Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963772Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963789Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963796Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963802Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963819Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963826Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963833Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963840Perfit ZRVatech mcis Co., LtdEIF2025-04-07