FDA.report

Concise™

Primary DI
00652221047892
Brand
Concise™
Company
3M UNITEK CORPORATION
Model
196-010
Catalog number
196-010
Device description
Concise(TM) Enamel Bond Resin B Ea
Published
2016-09-24
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
false

Related Records

Contact Domains

Product Codes

CodeName
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00652221047892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221047892006522210478926522210478920652221047892

GMDN Terms

TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
008256356
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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006522213073233M™ Clarity™359-824359-8242024-11-22
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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
00840479203652EXCEL REGULARRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-13
07290115050035High-Q-Bond Bracket AdhesiveB.J.M. LABORATORIES LTDDYH2026-03-13
07290115051896Ideal 1 Orthodontic Bracket AdhesiveB.J.M. LABORATORIES LTDDYH2026-03-13
07290115051902High-Q-Bond BandB.J.M. LABORATORIES LTDDYH2026-03-13
00840479203317RELY A BONDRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-12
00840479202372PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202389PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202396PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202402PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202419PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202426PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202433PLASTIC CONDITIONERRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202440PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202457PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202464PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202570PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479201894LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201900LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201924LIGHT BOND THIN PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201931LIGHT BOND FILLED SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201948LIGHT BOND FILLED SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201979LIGHT BOND REGULAR SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201986LIGHT BOND MEDIUM PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201993LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202006LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202082MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202099MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202105MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202136METAL PRIMERRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202259PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10