FDA.report

3M™ Unitek™ Temporary Anchorage Device (TAD)

Primary DI
00652221153555
Brand
3M™ Unitek™ Temporary Anchorage Device (TAD)
Company
3M COMPANY
Model
8 mm
Catalog number
504-008
Device description
3M™ Unitek™ 504-008 MDI ORTHO IMPLANT 8MM
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
true

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00652221153555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221153555006522211535556522211535550652221153555

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
Width8Millimeter

Sterilization Methods

Method

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
false
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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