FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
10840326404925
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
615-550
Catalog number
615-550
Device description
Maxi-View Retrac. (Small)
Published
2022-11-02
Public version status
New
Distribution status
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
EIGRETRACTOR, ALL TYPES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326404925PackageGS11In Commercial Distribution
00840326404928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032640492510840326404925
00840326404928008403264049288403264049280840326404928

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

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71000TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB71020TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB71030TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB7990TBS BASICSACME ENTERPRISE.EIG2026-05-22
00190776417567MillenniumAvalign Technologies, Inc.EIG2026-03-04
B382SD1472510000Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118280Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118290Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118300Surgical DirectSurgical Direct, Inc.EIG2026-02-16
04059453109095Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEIG2026-02-13
B382SD5750050Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD9177181010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD921052010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
00888118150608RETRACTORKLS-Martin L.P.EIG2025-12-23
00810123209712Adler Instrument CompanyAdler, Inc.EIG2025-12-12
B382SD62584SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
B382SD62585SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
B382SD62586SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
00810042124844OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
00810042124851OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
00810042124868OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
B382SD915100320Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100340Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100360Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100430Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100440Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100460Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100480Surgical DirectSurgical Direct, Inc.EIG2025-11-11
10190707191150Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
10190707191167Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23