FDA.reportPublic FDA data

Edge-Ease™ Cushions

Primary DI
10732224002962
Brand
Edge-Ease™ Cushions
Company
CROSSTEX INTERNATIONAL, INC.
Model
BWEEB
Device description
X-Ray cushions, Blue
Published
2022-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGZHolder, film, x-ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852170000EZX YELLOW, BLUE OR ORANGEStrong Marketing1985-09-05EGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224002960PackageGS112In Commercial Distribution
10732224002962PrimaryGS10
00732224002965Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400296050732224002960
1073222400296210732224002962
00732224002965007322240029657322240029650732224002965

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, single-useA device designed to stabilize a dental x-ray film intraorally during the taking of a dental x-ray. It is typically an adhesive-backed device designed to fold into a T-shape which adheres to the x-ray film and provides a tab that, when bitten down on, stabilizes the film adjacent to the teeth whilst the x-ray is being taken. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
300
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10732224002993Bite Wing-Ease™ Barrier SleevesBWES2022-09-29
10732224003044Slip-Ease™ CushionsBWSEL2022-09-29
10732224003068Wrap-Ease™ CushionsBWWEL2022-09-29
10732224003549Advantage Plus Cotton Tipped ApplicatorsH3AC2022-08-19
10732224003556Advantage Plus Cotton Tipped ApplicatorsH6AC2022-08-19
10732224120499Surgical Tie-On MaskGCS2022-05-06
50732224001291Polyback™ TowelsWPXFP2022-10-31
50732224001321Polyback™ TowelsWPXTB2022-10-31
50732224002359Econoback™ TowelsWEXFP2022-10-31
50732224002366Econoback™ TowelsWEXTB2022-10-31
50732224003936Non-Woven Headrest coversL3CB2022-09-29
50732224004841Professional Regular TowelsWTXFPWTXFP2023-07-17
30732224001136Self-Sealing Sterilization BagOCS2022-05-03
50732224005206Premium Non-Woven SpongesENCNW4KENCNW4K2025-10-23
50732224001086Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2025-10-23
10732224001088Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2022-08-25
10732224005208Premium Non-Woven SpongesENCNW4KENCNW4K2023-07-17
50732224000140Sani Vac Evacuation System CleanerJVACSAMPLESJVACSAMPLES2022-08-19
10732224110568Duo-Check Self-Sealing Sterilization PouchesSCM2025-07-24
10732224000050Crosstex InternationalSCMSCM2016-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D090101399140DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399150DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399160DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399170DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399180DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399190DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461070DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461090DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461480DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461490DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461500DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461510DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461520DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
00856145008926Two ClikrayONE Universal Holders WINE + Two G-Rings and RodsCLIKTECH LLCEGZ2026-07-17
00840456221891JMUJMU DENTAL, INCEGZ2026-06-08
00840456221907JMUJMU DENTAL, INCEGZ2026-06-08
00840456221914JMUJMU DENTAL, INCEGZ2026-06-08
00840456221921JMUJMU DENTAL, INCEGZ2026-06-08
00840456221938JMUJMU DENTAL, INCEGZ2026-06-08
00840456221945JMUJMU DENTAL, INCEGZ2026-06-08
00840456222317JMUJMU DENTAL, INCEGZ2026-06-08
00840456222324JMUJMU DENTAL, INCEGZ2026-06-08
00840456222331JMUJMU DENTAL, INCEGZ2026-06-08
00840456222348JMUJMU DENTAL, INCEGZ2026-06-08
00840456222355JMUJMU DENTAL, INCEGZ2026-06-08
00840456222362JMUJMU DENTAL, INCEGZ2026-06-08
00840456221884JMUJMU DENTAL, INCEGZ2026-06-05
10371347019633Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
10304040192112CarinaHENRY SCHEIN, INC.EGZ2025-05-13
08717228440007DenBiteDuPhaMed B.V.EGZ2023-11-24