FDA.reportPublic FDA data

3M™ ESPE™ Iso-Form™

Primary DI
50605861021710
Brand
3M™ ESPE™ Iso-Form™
Company
3M COMPANY
Model
SBB-4-5
Catalog number
SBB-4-5
Device description
3M™ ESPE™ Iso-Form™ Crown Bicuspid Stretch Block, SBB45
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
ELZCROWN, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50605861021710PackageGS110In Commercial Distribution
30605861021716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060586102171050605861021710
3060586102171630605861021716

GMDN Terms#

Term, Definition table
TermDefinition
Preformed dental crown, temporaryA prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth to serve as a temporary protective device. This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830016148
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
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
088877192573983M™186018602016-08-03
088877192574043M™1860S1860S2016-08-03
506380604335343M™ Aura™1870+1870+2022-06-02
000511312755393M™186018602016-08-03
000511312755463M™1860S1860S2016-08-03
00051131498556VFlex™180518052016-08-03
00051131498563VFlex™1805S1805S2016-08-03
00051131499966Aura™1870+1870+2016-08-03
000680608569683M186018602024-10-25
000680608581223M1860S1860S2024-10-25
006380604309583M™ Aura™1870+1870+2021-08-26
006380604313443M™ Aura™1870+BULK1870+BULK2020-10-22
006380604335463M™ Aura™1870+1870+2022-06-02
007073874194243M™186018602016-08-03
007073874441293M™1860S1860S2016-08-03
300511312759293M™ Vflex™180418042018-02-21
300511312759363M™ Vflex™1804S1804S2018-02-21
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906154842393Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842409Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842416Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842423Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842430Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842447Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842454Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842461Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842478Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842485Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842492Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842508Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842515Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842522Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842539Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842546Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842553Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842560Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842577Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842584Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842591Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842607Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842614Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842621Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842638Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843352Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843369Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843376Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843444Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843451Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30