FDA.reportPublic FDA data

ScanBox pro

Primary DI
03770021392855
Brand
ScanBox pro
Company
DENTAL MONITORING
Model
001
Catalog number
1012-001
Device description
Cheeck Retractor for photo acquisition. ScanBox pro M-L Pack (without boxabox, plastic bag only) -The kit contains 4 elements: 2 Cheek Retractors: one Medium size (M) and one Large size (L). 1 Adapter 1 Phone support.
Published
2024-09-16
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
false

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
03770021392039Direct MarkingGS10
03760405340183PackageGS112In Commercial Distribution
03760405340190PackageGS136In Commercial Distribution
03770021392855PackageGS136In Commercial Distribution
03770021392824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770021392039037700213920393770021392039
03760405340183037604053401833760405340183
03760405340190037604053401903760405340190
03770021392855037700213928553770021392855
03770021392824037700213928243770021392824

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
269129881
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760405340350DentalMonitoring0032001-0012026-07-21
03760405340404DentalMonitoring - Straumann0032001-0012026-07-21
03760405340411DentalMonitoring - Candid0032001-0012026-07-21
03760405340428DentalMonitoring - Smile Doctors0032001-0012026-07-21
03760405340237DentalMonitoring - Smile Doctors0032001-0012025-06-06
03760405340244DentalMonitoring - Candid0032001-0012025-06-06
03760405340251DentalMonitoring - Straumann0032001-0012025-06-06
03770021392114DentalMonitoring0032001-0012024-12-02
03760405340282LED AdapterLED Adapter1016-0012025-12-17
03760405340121ScanBox pro Smile Doctors0011012-0012025-02-14
03760405340145ScanBox pro Smile doctors0011014-0012025-02-14
03760405340169ScanBox pro - Candid 0011015-0012025-02-14
03760405340206ScanBox pro 0011014-0012025-02-14
03760405340138ScanBox pro Smile Doctors0011012-0012025-02-14
03760405340152ScanBox pro Smile doctors0011014-0012025-02-14
03760405340176ScanBox pro - Candid 0011015-0012025-02-14
03760405340213ScanBox pro 0011014-0012025-02-14
03770021392824ScanBox pro 0011012-0012024-09-16
03770021392879ScanBox pro - Smile Doctors0011009-0012024-09-16
03770021392886ScanBox pro - Smile Doctors0011010-0012024-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00883205029102OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029119OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029126OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029133OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029140OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029157OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00190776426491MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426514MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426521MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426538MillenniumAvalign Technologies, Inc.EIG2026-08-18
G8791030240DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103024L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030260DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791030380DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791031820DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791031830DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791048560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791062470DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G8791062480DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879KLB25060DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879KLB36110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879KLB40110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB30100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB35140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879LB4013DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879OBG30100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15