FDA.report

Ortho Veneer System

Primary DI
D798OVS0
Brand
Ortho Veneer System
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
OVS
Catalog number
OVS
Device description
OVS is intended for use as a composite system for the fabrication of veneers on undersized teeth. The kit contains 1 X 3cc Light Bond Sealant, 1 X 2.5g Ortho Veneer paste shade B-1, 1 X 2.5g Ortho Veneer shade A-1, 1 X 2.5g Ortho Veneer shade A-2, (5 Medium and 5 Large) Faci Forms Crown Form #12, (5 Medium and 5 Large) Faci Forms Crown Form #22, 1 X (16) Stick and Place instruments
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798OVS0PrimaryHIBCC0

GMDN Terms

TermDefinition
Custom-made dental composite resin kitA collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature (15-30 Degrees C)

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840479203300RELIAMOLDSRMKB2026-03-12
00840479203317RELY A BONDRPF2026-03-12
00840479203324RELIAWAXRWX2026-03-12
00840479203331RELIAWAXRWXSAM2026-03-12
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00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESSAMBAB22026-03-12
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