FDA.reportPublic FDA data

Edge™ Diamond TSE016-8M Tapered Safe-End

Primary DI
07540172013000
Brand
Edge™ Diamond TSE016-8M Tapered Safe-End
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
194963
Catalog number
194963
Device description
Dental diamond bur, re-useable
Published
2020-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540172013000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172013000075401720130007540172013000

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. 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(800)265-3444info@clinicianschoice.com

Regulatory Flags#

DUNS number
626406016
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540172009539Frost™ 37% Phosphoric Acid Etch 30ml3453013453012016-09-16
07540172009546Frost™ 37% Phosphoric Acid Etch 5ml3455013455012016-09-16
07540172010795Max Etch 35% Phosphoric Acid Etch 30ml3453023453022016-09-16
07540172010801Max Etch 35% Phosphoric Acid Etch 5ml3455033455032016-09-16
07540172019125G5 All-Purpose Desensitizer2261052261052024-09-23
07540172019132G5 All-Purpose Desensitizer2261102261102024-09-23
07540172019514Evanesce™ Nano-Enhanced Universal Restorative A2U Single Dose Sample9732129732122024-09-17
07540172019644Evanesce™ Silk Nano-Enhanced Universal Restorative A1E Single Dose3235703235702024-09-17
07540172019651Evanesce™ Silk Nano-Enhanced Universal Restorative A2E Single Dose3235713235712024-09-17
07540172019668Evanesce™ Silk Nano-Enhanced Universal Restorative A3E Single Dose3235723235722024-09-17
07540172019675Evanesce™ Silk Nano-Enhanced Universal Restorative B1E Single Dose3235733235732024-09-17
07540172019682Evanesce™ Silk Nano-Enhanced Universal Restorative A2D Single Dose3235743235742024-09-17
07540172019699Evanesce™ Silk Nano-Enhanced Universal Restorative A3D Single Dose3235753235752024-09-17
07540172019705Evanesce™ Silk Nano-Enhanced Universal Restorative B2U Single Dose3235763235762024-09-17
07540172019712Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose3235773235772024-09-17
07540172019729Evanesce™ Silk Nano-Enhanced Universal Restorative A2U Single Dose Sample9732119732112024-09-17
07540172019507MPa Universal™ Light-Cure Universal Adhesive Unit Dose Sample9732669732662024-08-09
07540172002363Green Mouldable Edentulous Trays Size 211884211884212020-10-22
07540172001861D-Fine Double Diamond™ Primary Polisher Refill #091315091315092020-10-22
07540172001953D-Fine Double Diamond™ Final High Shine Refill #091325091325092020-10-22

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00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
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00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
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00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25
00810226101081AiraAIRA, LLCEJL2026-08-25