FDA.reportPublic FDA data

EXACTGUIDE

Primary DI
D690TGH0425210
Brand
EXACTGUIDE
Company
Ss White Burs, Inc.
Model
UTGH042521
Catalog number
TGH042521
Device description
EXACTGUIDE ROTARY FILE 25/.04 RED 21MM - 4 PACK
Published
2025-02-17
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
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D690TGH0425212PrimaryHIBCC0
D690TGH0425210Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
151760014
Device count
4
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
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 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
07640452461030EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461047EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461054EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461061EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461078EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461085EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461092EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461108EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461115EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461122EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461139EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461146EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461153EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461160EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461177EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461184EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461191EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461207EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461214EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461221EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461238EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461245EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461252EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461269EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452462235EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462242EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462259EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462266EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462273EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462280EdgeTaperFKG Dentaire SàrlEKS2026-06-03