FDA.reportPublic FDA data

Sledgehammer

Primary DI
H66810005411
Brand
Sledgehammer
Company
Keystone Industries
Model
1000541
Catalog number
1000541
Device description
SC 25 lb Pwd & 4 Qt Liq Kit, Lt Fibered
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983876000MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLICMycone Dental Supply Co., Inc. (A/K/A Keystone Ind1998-12-16EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66810005411PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from moisture
Special Storage Condition, Specify00Keep out of direct sunlight
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)333-3131tschwear@keystoneind.com

Regulatory Flags#

DUNS number
073503117
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
H66842201141HeyGears422011442201142023-02-20
H66842201151KeySplint Soft for HeyGears422011542201152021-07-06
H66850524011Nexa3D425020542502052023-02-20
H66852233011Nexa3D425020442502042023-02-20
H6682030051iSmile070137707013772023-02-20
H66807003771Seity070037707003772016-09-15
H66807021771M&S070217707021772017-10-11
H66807027771Seity070277707027772016-10-26
H66842204400Carbon 422044042304402025-08-28
H66842204410Carbon 422044142304412025-08-28
H66842204420Carbon 422044242304422025-08-28
H66842204401Carbon 422044042304402025-08-28
H66842204411Carbon 422044142304412025-08-28
H66842204421Carbon 422044242304422025-08-28
H668166361BOSWORTH16636166362022-11-30
H668166961BOSWORTH16696166962022-11-30
H66811475771Keystone Industries114757711475772022-11-30
H66811475781Keystone Industries114757811475782022-11-30
H668166301BOSWORTH16630166302022-11-30
H668166321BOSWORTH16632166322022-11-30

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