FDA.report

3M™ Unitek™ OrthoForm™

Primary DI
00652221052148
Brand
3M™ Unitek™ OrthoForm™
Company
3M UNITEK CORPORATION
Model
300-573
Catalog number
300-573
Device description
Unitek(TM) Permachrome Resilient Stainless Steel OrthoForm(TM) Level Anchorage U .018x.025 10/Pk
Published
2018-10-18
Public version status
New
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

Contact Domains

Product Codes

CodeName
DZCWIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00652221052148PrimaryGS10
80652221052144Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221052148006522210521486522210521480652221052148
8065222105214480652221052144

GMDN Terms

TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)423-45883Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
008256356
Device count
10
DM exempt
false
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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006522213072623M™ Clarity™359-822359-8222024-11-22
006522213072793M™ Clarity™359-823359-8232024-11-22
006522213072863M™ Clarity™359-830359-8302024-11-22
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006522213073093M™ Clarity™359-832359-8322024-11-22
006522213073163M™ Clarity™359-833359-8332024-11-22
006522213073233M™ Clarity™359-824359-8242024-11-22
006522213073303M™ Clarity™359-825359-8252024-11-22
006522213073473M™ Clarity™359-826359-8262024-11-22
006522213073543M™ Clarity™359-827359-8272024-11-22
006522213073613M™ Clarity™359-834359-8342024-11-22
006522213073783M™ Clarity™359-835359-8352024-11-22
006522213073853M™ Clarity™359-836359-8362024-11-22
006522213073923M™ Clarity™359-837359-8372024-11-22
106058610857693M™EX-1009795EX-10097952024-03-28
806522211619073M™ Unitek™504-319504-3192022-12-08
006522213033563M™ Unitek™404-116404-1162023-06-22
006522213033633M™ Unitek™404-126404-1262023-06-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840479203621RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-13
00840479203249RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203256RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203263RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203294RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203300RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203461ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203133RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203140RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203157RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203164RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203171RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203188RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203195RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203201RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203218RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479202198ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202204ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202235ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202242ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479201146DISPOSABLE C&C OVAL APPLICATOR WITHOUT CHAIN (1)RELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-04
00840479201153DISPOSABLE C&C PAD ATTACHMENT WITH CHAIN (1)RELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-04
00840479200828BOND A BRAID 6 INCH LINGUAL RETAINER WIRESRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-23
00840479200415RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200422RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200439RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200446RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200453RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200460RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20