FDA.report

Kobayashi Tie Hooks

Primary DI
D798SK141
Brand
Kobayashi Tie Hooks
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
SK14
Catalog number
SK14
Device description
Kobayashi Tie Hooks are intended for use to secure rubber bands to a bracket and elastics. This version is hook size .014 with short wire length.
Published
2016-07-27
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
true

Related Records

Product Codes

CodeName
DZCWire, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798SK141PrimaryHIBCC0
D798SK140Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic archwire/bracket ligatureA device intended to hold an orthodontic archwire securely in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie or circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient conditions.

Sterilization Methods

Method

Contacts

PhoneEmail
630-773-4009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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