FDA.reportPublic FDA data

PRO-ELAST

Primary DI
00810152822098
Brand
PRO-ELAST
Company
Ortho Pro Dent LLC
Model
ELRC-700
Device description
ELASTOMERIC ROTATION WEDGE CLEAR 100/PK
Published
2024-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECIBand, Elastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152822098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152822098008101528220988101528220980810152822098

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
941-402-6504edward@orthoprodent.com

Regulatory Flags#

DUNS number
085719913
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152820902MAX-BONDOP96b-042024-11-04
00810152820919MAX-BONDOP96b-152024-11-04
00810152825556Orthodontic PlierOP-1002024-11-06
00810152825563Orthodontic PlierOP-1022024-11-06
00810152825570Orthodontic PlierOP-1032024-11-06
00810152825587Orthodontic PlierOP-1042024-11-06
00810152825594Orthodontic PlierOP-1052024-11-06
00810152825600Orthodontic PlierOP-1062024-11-06
00810152825617Orthodontic PlierOP-1072024-11-06
00810152825624Orthodontic PlierOP-1082024-11-06
00810152825631Orthodontic PlierOP-1092024-11-06
00810152825648Orthodontic PlierOP-1102024-11-06
00810152825655Orthodontic PlierOP-1112024-11-06
00810152825662Orthodontic PlierOP-1122024-11-06
00810152825679Orthodontic PlierOP-1132024-11-06
00810152825686Orthodontic PlierOP-1142024-11-06
00810152825693Orthodontic PlierOP-1152024-11-06
00810152825709Orthodontic PlierOP-1162024-11-06
00810152825716Orthodontic PlierOP-1172024-11-06
00810152825723Orthodontic PlierOP-1182024-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205020JMUJMU DENTAL, INCECI2026-06-22
00840456205037JMUJMU DENTAL, INCECI2026-06-22
00840456205044JMUJMU DENTAL, INCECI2026-06-22
00840456205051JMUJMU DENTAL, INCECI2026-06-22
00840456205068JMUJMU DENTAL, INCECI2026-06-22
00840456205075JMUJMU DENTAL, INCECI2026-06-22
00840456205082JMUJMU DENTAL, INCECI2026-06-22
00840456205099JMUJMU DENTAL, INCECI2026-06-22
00840456205105JMUJMU DENTAL, INCECI2026-06-22
00840456205112JMUJMU DENTAL, INCECI2026-06-22
00840456205129JMUJMU DENTAL, INCECI2026-06-22
00840456205136JMUJMU DENTAL, INCECI2026-06-22
00840456205143JMUJMU DENTAL, INCECI2026-06-22
00840456205150JMUJMU DENTAL, INCECI2026-06-22
00840456205167JMUJMU DENTAL, INCECI2026-06-22
00840456205174JMUJMU DENTAL, INCECI2026-06-22
00840456205181JMUJMU DENTAL, INCECI2026-06-22
00840456205198JMUJMU DENTAL, INCECI2026-06-22
00840456205204JMUJMU DENTAL, INCECI2026-06-22
00840456205211JMUJMU DENTAL, INCECI2026-06-22
00840456205228JMUJMU DENTAL, INCECI2026-06-22
00840456205235JMUJMU DENTAL, INCECI2026-06-22
00840456205242JMUJMU DENTAL, INCECI2026-06-22
00840456205259JMUJMU DENTAL, INCECI2026-06-22
00840456205426JMUJMU DENTAL, INCECI2026-06-22
00840456205433JMUJMU DENTAL, INCECI2026-06-22
00840456205440JMUJMU DENTAL, INCECI2026-06-22
00840456205457JMUJMU DENTAL, INCECI2026-06-22
00840456205464JMUJMU DENTAL, INCECI2026-06-22
00840456205471JMUJMU DENTAL, INCECI2026-06-22