FDA.reportPublic FDA data

SCOTT'S HANDHELD AUTOMIX CORE 2/pk BLUE

Primary DI
D77819930651
Brand
SCOTT'S HANDHELD AUTOMIX CORE 2/pk BLUE
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
199-3065
Catalog number
199-3065
Published
2017-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022675000PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIALPrime Dental Manufacturing, Inc.2002-11-07EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77819930651PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags#

DUNS number
137217043
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D77819910111SCOTT'S SELECT 37% ETCH GEL 1.2ml SYRINGE KIT 4/pk199-1011199-10112017-05-24
D77819910121SCOTT'S SELECT 37% ETCH GEL 12gm BULK SYRINGE KIT199-1012199-10122017-05-24
D77819910131SCOTT'S SELECT 37% ETCH GEL 50mL JUMBO SYRINGE KIT199-1013199-10132017-05-24
D77819910141SCOTT'S SELECT 37% ETCH GEL 50mL JUMBO SYRINGE199-1014199-10142017-05-24
D77819910081SCOTT'S SELECT AUTOMIX 25ml TEMP CEMENT NE199-1008199-10082017-06-02
D77819910451SCOTT'S SELECT TEMP AUTOMIX NE 11gm199-1045199-10452017-06-02
D77818810880SCOTT'S MORREL CROWN REMOVER w/ 4-TIPS188-1088188-10882021-02-27
D77818820080SCOTT'S CROWN GRABBER REMOVER188-2008188-20082021-02-27
D77818831030SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS188-3103188-31032021-02-27
D77810702991Scott's Select Non-Woven Sponges 2 x 2 107-0299107-02992024-08-27
D77810704441Scott's Select Non-Woven Sponges 4 x 4107-0444107-04442024-08-27
D77810320011Scott's Select Mirror Handle Cone Socket Octagonal103-2001103-20012024-09-05
D77810320021Scott's Select Mirror Handle Cone Socket Round103-2002103-20022024-09-05
D77810320031Scott's Select Mouth Mirror Front Surface #3103-2003103-20032024-09-05
D77810320041Scott's Select Mouth Mirror Front Surface #4103-2004103-20042024-09-05
D77810320051Scott's Select Mouth Mirror Front Surface #5103-2005103-20052024-09-05
D77810750051"SCOTT'S SYRINGE SLEEVE 2.5""x10"" (500) CLEAR"107-5005107-50052021-02-27
D77810750061"SCOTT'S SYRINGE SLEEVE 2.5""x10"" (500) BLUE"107-5006107-50062021-02-27
D77810750071"SCOTT'S FULL CHAIR COVER 29"" X 80"" (125/bx)"107-5007107-50072021-02-27
D77810750091"SCOTT'S HALF CHAIR CVR 27.5"" X 24"" (225/bx)"107-5009107-50092021-02-27

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00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
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00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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