FDA.reportPublic FDA data

Denovo Clearfield cheek retractors

Primary DI
00810059291478
Brand
Denovo Clearfield cheek retractors
Company
Denovo Dental, Inc.
Model
430-400
Device description
Denovo Clearfield cheek retractors - size small
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00810059291478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810059291478008100592914788100592914780810059291478

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
183498179
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810059291584Denovo Dental Crown Removing Plier800-015 2023-06-30
00810059291256Dental Matrix System Wedges180-411 2023-06-30
00810059291263Dental Matrix System Wedges180-4132023-06-30
00810059290006Denovo general purpose dental molar band160-1462023-06-30
00810059290013Denovo general purpose dental molar band160-147 2023-06-30
00810059290020Denovo general purpose dental molar band160-148 2023-06-30
00810059290037Denovo general purpose dental molar band160-1492023-06-30
00810059290044Denovo general purpose dental molar band160-150 2023-06-30
00810059290051Denovo general purpose dental molar band160-151 2023-06-30
00810059290068Denovo general purpose dental molar band160-152 2023-06-30
00810059290075Denovo general purpose dental molar band160-153 2023-06-30
00810059290082Denovo general purpose dental molar band160-154 2023-06-30
00810059290099Denovo general purpose dental molar band160-155 2023-06-30
00810059290105Denovo general purpose dental molar band160-156 2023-06-30
00810059290112Denovo general purpose dental molar band160-157 2023-06-30
00810059290129Denovo general purpose dental molar band160-158 2023-06-30
00810059290143Denovo general purpose dental molar band160-160 2023-06-30
00810059290150Denovo general purpose dental molar band160-161 2023-06-30
00810059290167Denovo general purpose dental molar band160-162 2023-06-30
00810059290174Denovo general purpose dental molar band160-163 2023-06-30

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