FDA.reportPublic FDA data

EXIMIA7

Primary DI
16976245260299
Brand
EXIMIA7
Company
Ss White Burs, Inc.
Model
030/06-H
Catalog number
PPX73006
Device description
EXEMIA 7 PAPER POINTS 30/.06 - 100 PACK
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKNPOINT, PAPER, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976245260292PrimaryGS10
16976245260299Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976245260292069762452602926976245260292
1697624526029916976245260299

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(732)905-1100customerservice@sswhitedental.com

Regulatory Flags#

DUNS number
151760014
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
D6903100452SSW CARBIDEHP-PBUR-1/43100452026-02-16
D6903100472SSW CARBIDEHP-PBUR-13100472026-02-16
D6903100482SSW CARBIDEHP-PBUR-23100482026-02-16
D6903100492SSW CARBIDEHP-PBUR-33100492026-02-16
D6903100502SSW CARBIDEHP-PBUR-43100502026-02-16
D6903100512SSW CARBIDEHP-PBUR-53100512026-02-16
D6903100522SSW CARBIDEHP-PBUR-63100522026-02-16
D6903100532SSW CARBIDEHP-PBUR-73100532026-02-16
D6903100542SSW CARBIDEHP-PBUR-83100542026-02-16
D6903100552SSW CARBIDEHP-PBUR-SC103100552026-02-16
D6903100572SSW CARBIDEHP-PBUR-33-1/23100572026-02-16
D6903100612SSW CARBIDEHP-PBUR-373100612026-02-16
D6903100672SSW CARBIDEHP-PBUR-5583100672026-02-16
D6903100722SSW CARBIDEHP-PBUR-6993100722026-02-16
D6903100732SSW CARBIDEHP-PBUR-7003100732026-02-16
D6903100742SSW CARBIDEHP-PBUR-7013100742026-02-16
D6903100752SSW CARBIDEHP-PBUR-7023100752026-02-16
D6903100772SSW CARBIDEHP-PBUR-7033100772026-02-16
D6903100932SSW CARBIDEFG-PBUR-1/23100932026-02-16
D6903100952SSW CARBIDEFG-PBUR-13100952026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800069213463Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213470Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213487Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213494Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213500Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213517Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213524Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213531Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213548Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213555Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213562Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213579Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213586Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213593Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213609Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213616Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213142Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213159Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213166Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213173Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069204850XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204867XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204874XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204881XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204898XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069209497Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209503Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209510Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209527Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209534Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16