FDA.report

ACCESS

Primary DI
D798CH10
Brand
ACCESS
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
CH1
Catalog number
CH1
Device description
The ACCESS™ Cheek Retractors are intended for use in pulling the cheeks back from the buccal and labial surfaces of the teeth during orthodontic procedures. Adult Size - Special posterior pads comfortably hold the cheeks away and allow excellent "accessibility" to the bicuspid and molar area. Spring stainless steel bow allows for adjustment and pivot points provide greater comfort.
Published
2016-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798CH10PrimaryHIBCC0

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient conditions.

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
1
DM exempt
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840479201481RENEW SYSTEM POINTSFGSAM22026-03-13
00840479203614ULTRA VIOLET MINI LIGHTUVML2026-03-13
00840479203621RETAINIUM LINGUAL RETENTION WIREXLRETSAM2026-03-13
00840479203652EXCEL REGULARERJAF2026-03-13
00840479203669SYRINGE WING (1)WING2026-03-13
00840479203249RETAINIUM LINGUAL RETENTION WIRERET2026-03-12
00840479203256RETAINIUM LINGUAL RETENTION WIREXLRET2026-03-12
00840479203263RETAINIUM LINGUAL RETENTION WIRERETSAM2026-03-12
00840479203270MIXING RESERVOIR RING WELRW2026-03-12
00840479203287MIXING RESERVOIR RING WELRWSAM2026-03-12
00840479203294RELIAMOLDSRMK2026-03-12
00840479203300RELIAMOLDSRMKB2026-03-12
00840479203317RELY A BONDRPF2026-03-12
00840479203324RELIAWAXRWX2026-03-12
00840479203331RELIAWAXRWXSAM2026-03-12
00840479203348SPATULAS2026-03-12
00840479203355SAFETY GLASSESSG2026-03-12
00840479203362SAFETY GLASSESSGU2026-03-12
00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESSAMBAB22026-03-12
00840479203409SELF ETCHING PRIMER REFILL CARTRIDGESEPR2026-03-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-UseArmor Dental Corp.EIF2025-05-12
08800099963765Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963772Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963789Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963796Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963802Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963819Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963826Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963833Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963840Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963857Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963864Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963871Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963888Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963895Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963901Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963918Perfit ZRVatech mcis Co., LtdEIF2025-04-07