FDA.reportPublic FDA data

SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS

Primary DI
D77818831030
Brand
SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
188-3103
Catalog number
188-3103
Device description
SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EISREMOVER, CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77818831030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis removerA non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
137217043
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D77810701992Scott's Select Cotton Rolls107-0199107-01992024-08-27
D77810702990Scott's Select Non-Woven Sponges 2 x 2 107-0299107-02992024-08-27
D77810704440Scott's Select Non-Woven Sponges 4 x 4107-0444107-04442024-08-27
D77810750500Scott's Select Patient Bibs107-5050107-50502024-08-27
D77810750540Scott's Select Patient Bibs107-5054107-50542024-08-27
D77810750560Scott's Select Patient Bibs107-5056107-50562024-08-27
D77810750580Scott's Select Patient Bibs107-5058107-50582024-08-27
D77819950610Scott's Select ColorFil Flow Single-Shade Prismatic199-5061199-50612024-08-27
D77819950630Scott's Select ColorFil Flow Blocker199-5063199-50632024-08-27
D77819950500Scott's Select ColorFil Single-Shade Prismatic199-5050199-50502024-08-26
D77819950530Scott's Select ColorFil Blocker199-5053199-50532024-08-26
D77819950570Scott's Select ColorFil Single-Shade Prismatic199-5057199-50572024-08-26
D77819950590Scott's Select ColorFil Blocker199-5059199-50592024-08-26
D77835054990Scott's Select Nitrile Gloves350-5499350-54992024-08-22
D77835055000Scott's Select Nitrile Gloves350-5500350-55002024-08-22
D77835055050Scott's Select Nitrile Gloves350-5505350-55052024-08-22
D77835055110Scott's Select Nitrile Gloves350-5511350-55112024-08-22
D77835086300Scott's Select Latex Gloves350-8630350-86302024-08-22
D77835086320Scott's Select Latex Gloves350-3632350-36322024-08-22
D77835086340Scott's Select Latex Gloves350-8634350-86342024-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G14934001F08TBS DentalACME ENTERPRISE.EIS2026-03-02
04963931210794NAYDM CORPORATIONEIS2025-12-05
04963931210800NAYDM CORPORATIONEIS2025-12-05
00841336106086Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108646Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108660Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336100916Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125551Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125568Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125575Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125582Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125599Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
06974456210815CICADAFoshan Cicada Dental Instrument Co., Ltd.EIS2024-08-10
00813677025098PDT, Inc.PDT, INC.EIS2024-07-03
00813677023292PDT, Inc.PDT, INC.EIS2024-07-02
00813677024565PDT, Inc.PDT, INC.EIS2024-07-02
00813677023285PDT, Inc.PDT, INC.EIS2024-07-01
00813677023544PDT, Inc.PDT, INC.EIS2024-07-01
00813677023551PDT, Inc.PDT, INC.EIS2024-07-01
D105SKU1311760SurgiMac Surgimac LLCEIS2024-05-10
00842517107366Karl SchumacherKarl Schumacher Dental, LLCEIS2024-03-18
00842517107458Karl SchumacherKarl Schumacher Dental, LLCEIS2024-03-18
00842517107328Karl SchumacherKarl Schumacher Dental, LLCEIS2024-03-01
00842517107373Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107397Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107403Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107410Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107427Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107441Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107465Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27