FDA.reportPublic FDA data

3M™ ESPE™

Primary DI
50605861026630
Brand
3M™ ESPE™
Company
3M COMPANY
Model
914001
Catalog number
914001
Device description
3M™ ESPE™ Pedodontic Anterior Strip Crown Form, Upper Left Central, Size 1, 914001
Published
2018-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCQTUBE IMPRESSION AND MATRIX

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCQTube Impression And MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50605861026630PackageGS15In Commercial Distribution
30605861026636PrimaryGS10
00605861023955Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060586102663050605861026630
3060586102663630605861026636
00605861023955006058610239556058610239550605861023955

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
830016148
Device count
5
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15
007073877753083M™ Bair Hugger™55077550772026-05-15
007073877753153M™ Bair Hugger™55577555772026-05-15
007073878188833M™ Bair Hugger™54501545012026-05-15
007073878188903M™ Bair Hugger™55001550012026-05-15
007073878189063M™ Bair Hugger™55502555022026-05-15
007073878189133M™ Bair Hugger™58502585022026-05-15
007073878189203M™ Bair Hugger™63501635012026-05-15
007073878189373M™ Bair Hugger™57502575022026-05-15
007073878189443M™ Bair Hugger™45035450352026-05-15
007073878189513M™ Bair Hugger™45535455352026-05-15
007073878189683M™ Bair Hugger™55078550782026-05-15
007073878189753M™ Bair Hugger™55578555782026-05-15
106058610760643M™ Filtek™6555A3-S6555A3-S2026-05-08
106058610773823M™ Filtek™4867A14867A12026-05-08
106058610773993M™ Filtek™4867A24867A22026-05-08
106058610774053M™ Filtek™4867A34867A32026-05-08
106058610774123M™ Filtek™4867B14867B12026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075846108White BiteWhite Bite, Inc.KCQ2026-05-27
00850075846122White BiteWhite Bite, Inc.KCQ2026-05-27
008101265033053D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKCQ2025-12-16
008101265062143D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKCQ2025-12-16
00850056330008White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330015White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330022White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330039White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330046White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330053White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330060White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330077White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330084White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330091White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330107White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330114White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330121White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330138White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330145White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330152White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330169White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330176White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330183White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330206White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330220White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330237White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330244White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330251White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330541White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330558White BiteWhite Bite, Inc.KCQ2025-10-27