FDA.reportPublic FDA data

ScanBox pro

Primary DI
03770021392077
Brand
ScanBox pro
Company
DENTAL MONITORING
Model
001
Catalog number
1009-001
Device description
Cheeck Retractor for photo acquisition.ScanBox pro S-M Pack -The kit contains 3 elements:2 Cheek Retractors: one Small size (S) and one Medium size (M).1 Phone support.
Published
2022-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
03770021392015Direct MarkingGS10
03770021392091PackageGS112In Commercial Distribution
03770021392077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770021392015037700213920153770021392015
03770021392091037700213920913770021392091
03770021392077037700213920773770021392077

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.

Contacts#

Phone, Email table
PhoneEmail
+1 737 201 9002support@dental-monitoring.com

Regulatory Flags#

DUNS number
269129881
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

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