FDA.reportPublic FDA data

Border-Lock® Disposable Edentulous Lower Tray #21

Primary DI
07540172016209
Brand
Border-Lock® Disposable Edentulous Lower Tray #21
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
186421
Catalog number
186421
Device description
Dental impression tray, single-use
Published
2020-03-19
Public version status
New
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
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540172016209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172016209075401720162097540172016209

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use 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

Other Devices From This Company#

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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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D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
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