FDA.reportPublic FDA data

Ortho Pro

Primary DI
00810152825891
Brand
Ortho Pro
Company
Ortho Pro Dent LLC
Model
WAX-YL
Device description
Patient Relief Wax Lemon 50pcs/pk
Published
2024-11-05
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
EGDWax, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152825891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152825891008101528258918101528258910810152825891

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance relief materialA device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

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
EYET6530500M0 Sculp. Wax SPECIAL-Summer-Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET65505000 Sculp. Wax SPEZIAL winter Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6550500M0 Sculp. Wax SPEZIAL winter Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET66005000 Sculp. Wax SUPERPINK elastic, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6600500M0 Sculp. Wax SUPERPINK elastic, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET68000000SOLIDUS 80, base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6800000M0SOLIDUS 80, base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET68400000 SOLIDUS 84 base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6840000M0 SOLIDUS 84 base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
D800ZBAC6705WHI0Printer Resin Try-In & Burnout White (500g)ZIRKONZAHN SRLEGD2026-05-20
EYET60500600Bite regist. Metal foil wax, brownYeti Dentalprodukte GmbHEGD2026-05-11
EYET61001000Performed Bite rims, soft yellow “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6100100M0Performed Bite rims, soft yellow “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61101000 Performed Bite rims, hard, pink “strawb.”Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6110100M0 Performed Bite rims, hard, pink “strawb.”,Sample Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61204900Bite wax sticks, soft, yellow, “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6120490M0Bite wax sticks, soft, yellow, “lemon” ,SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61301000Performed Bite rims, medium “orange”, SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET6130100M0Performed Bite rims, medium “orange”, SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61304900Bite wax sticks, hard, pink, “strawb.” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6130490M0Bite wax sticks, hard, pink, “strawb.” , SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61401000Preformed Bite rims, very hard, pink Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6140100M0Preformed Bite rims, very hard, pink Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61404900 Bite wax sticks, medium, gree, “apple” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6140490M0 Bite wax sticks, medium, gree, “apple” ,SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET6840000SOLIDUS 84Yeti Dentalprodukte GmbHEGD2026-04-13
00840479203324RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479203331RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479200552RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
00840479200569RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23