FDA.reportPublic FDA data

OSE

Primary DI
00810042124844
Brand
OSE
Company
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Model
X009-006
Device description
X-SPANDER CLEAR CHEEK RETRACTOR - LARGE
Published
2025-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810042124844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042124844008100421248448100421248440810042124844

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
077801124
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042124875OSE8007-7772026-01-28
00810042124851OSEX009-0072025-11-26
00810042124868OSEX009-0082025-11-26
00869843000239Depend-On0169-0002016-07-29
00869843000277OSE0167-0002016-07-29
00869843000291OSE 8oz. Orthodontic Etching Gel - Blue240M-L002018-06-13
00810042124745OSE0202-0072023-08-11
00810042124752OSE0202-0082023-08-11
00810042124769OSE0202-0092023-08-11
00810042124738OSE0580-0122023-07-20
00810042124547OSE0202-F2023-06-21
00810042124554OSE0202-G2023-06-21
00810042124561OSE0202-H2023-06-21
00810042124578OSE0202-J2023-06-21
00810042124585OSE0202-K2023-06-21
00810042124592OSE0202-W2023-06-21
00810042124608OSE0202-Y2023-06-21
00810042124639OSE0202-N2023-06-21
00810042124646OSE0202-P2023-06-21
00810042124653OSE0202-V2023-06-21

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