FDA.report

3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit

Primary DI
00652221153586
Brand
3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit
Company
3M COMPANY
Model
504-101
Catalog number
504-101
Device description
Unitek™ TAD Introductory Kit. Implants in the kit are provided sterile by irradiation and have clinically relevant sizes. The instruments in the kit need to be moist heat/steam sterilized before use.
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00652221153586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221153586006522211535866522211535860652221153586

GMDN Terms

TermDefinition
Orthodontic anchoring screwA small metallic rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.

Device Sizes

TypeValueUnit
Length6Millimeter
Length8Millimeter
Length10Millimeter

Sterilization Methods

Method
Radiation Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)423-4588xx@xx.xx

Regulatory Flags

DUNS number
830016148
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
true

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