FDA.report

Pad Lock

Primary DI
D798PLTKAS0
Brand
Pad Lock
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
PLTKAS
Catalog number
PLTKAS
Device description
Pad Lock® is intended for use as a fluorescing, light cure orthodontic bracket adhesive. Pad Lock® paste will fluoresce when illuminated with a black light to reveal flash upon bracket placement. In addition, the cured paste under the bracket base will fluoresce at the time of debonding making it easier to see and remove the adhesive Kit contains 18g adhesive paste in dispensing tips, 1 X 6cc Assure Bonding Resin, 9 gm liquid etchant, mixing pad, spatulas and brush applicators. This is a non-Fluoride Kit.
Published
2016-08-10
Public version status
Update
Distribution status
Not 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
KLEAgent, Tooth Bonding, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798PLTKAS0PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store refrigerated (2-8 degrees C). Avoid excessive heat. Allow product to reach room temper ature prior to use.

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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00840479203270MIXING RESERVOIR RING WELRW2026-03-12
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00840479203355SAFETY GLASSESSG2026-03-12
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