FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105202134
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
CURESC-7SLC
Device description
Sinus-Lift Curette #7SLC (Dull) Satin Finish
Published
2019-11-26
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
EMKCURETTE, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105202134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105202134008401052021348401052021340840105202134

GMDN Terms#

Term, Definition table
TermDefinition
Dental sinus lift elevatorA hand-held, manual, dental surgical instrument specially designed to lift and displace sinus mucosa (Schneiderian membrane) from the maxillary sinus floor to allow for insertion of a bone graft during sinus lift surgery. It is typically a metal instrument with single- or double-ended blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(847)647-1819JEFF@ZOLLDENTAL.COM

Regulatory Flags#

DUNS number
005449822
Device count
1
DM exempt
false
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
00840105223801ZOLL DENTALZ-49352025-08-11
00840105223757ZOLL DENTALGK-TUN-K62025-08-06
00840105223764ZOLL DENTALGK-TUN-K72025-08-06
00840105223771ZOLL DENTALGK-TUN-K82025-08-06
00840105223788ZOLL DENTALGK-TUN-K92025-08-06
00840105223795ZOLL DENTALGK-TUN-K102025-08-06
00840105223740ZOLL DENTALZ-99972025-07-24
00840105223733ZOLLDENTALS-ST22025-03-17
00840105223726ZOLL DENTALZ-73012025-01-29
00840105223672ZOLL DENTALZ-13022024-12-18
00840105223689ZOLL DENTALZ-13032024-12-18
00840105223696ZOLL DENTALZ-47862024-12-18
00840105223702ZOLL DENTALZ-47872024-12-18
00840105223719ZOLL DENTALZ-47902024-12-18
00840105223658ZOLL DENTALZ-52585052024-12-11
00840105223665ZOLL DENTALZ-48205052024-12-11
00840105223641ZOLL DENTALZ-49862024-08-26
00840105223634ZOLL DENTALRET-UofMN-BENT2024-08-01
00840105223573ZOLL DENTALZ-49332024-07-29
00840105223597ZOLL DENTALZ-90322024-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783007831Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-03-17
B382SD9162110970Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD916211098Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD9162111000Surgical DirectSurgical Direct, Inc.EMK2026-03-02
G1493800400TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493800501TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493806204TBS DentalACME ENTERPRISE.EMK2026-03-02
G149TBSBP03TBS DentalACME ENTERPRISE.EMK2026-03-02
B382SD915585140Surgical DirectSurgical Direct, Inc.EMK2026-02-25
B382SD48713950600Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800240Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48810120Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000500Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570050Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915579000Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915580070Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155911020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
00841336106000Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106062Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106079Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106239Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106499Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106697Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106918Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336108639Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336108653Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336109421Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22