FDA.reportPublic FDA data

SurgiMac

Primary DI
D105SKU1214070
Brand
SurgiMac
Company
Surgimac LLC
Model
12-1407
Catalog number
12-1407
Device description
7R, Knives, Pro Series.
Published
2024-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EGDWax, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D105SKU1214070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal knifeA hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060635048
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D105VP9008MI4MacImpressVP-9008-MIVP9008MI2026-07-06
D1051013021MacSafe10-13021013022026-06-26
D1051013031MacSafe10-13031013032026-06-26
D1051013041MacSafe10-13041013042026-06-26
D1051013011MacSafe10-13011013012026-06-25
D105VP9008MI10MacImpress VP-9008-MI-12025-11-07
D105VP9007MI2MacImpress VP-9007-MI2025-09-25
D105VP9011MI2MacImpress VP-9011-MI2025-09-25
D105VP9007MI11MacImpress VP-9007-MI-12025-09-25
D105VP9007MI21MacImpress VP-9007-MI2025-09-25
D105VP9011MI11MacImpress VP-9011-MI-12025-09-25
D105VP9011MI21MacImpress VP-9011-MI2025-09-25
D105121781MacBite121782025-08-15
D1051217840MacBite12178-42025-08-15
D105121789MacBite121782025-08-15
D1051217849MacBite12178-42025-08-15
D1057115XS0MacTouch 7115-XS2025-08-14
D1057115XSCS1MacTouch 7115-XS-CS2025-08-14
D1057116S0MacTouch 7116-S2025-08-14
D1057116SCS1MacTouch 7116-S-CS2025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456200193JMUJMU DENTAL, INCEGD2026-06-22
00840456224144JMUJMU DENTAL, INCEGD2026-06-22
00840456224151JMUJMU DENTAL, INCEGD2026-06-22
00840456224168JMUJMU DENTAL, INCEGD2026-06-22
00840456224175JMUJMU DENTAL, INCEGD2026-06-22
00840456224182JMUJMU DENTAL, INCEGD2026-06-22
EYET6530500M0 Sculp. Wax SPECIAL-Summer-Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET65505000 Sculp. Wax SPEZIAL winter Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6550500M0 Sculp. Wax SPEZIAL winter Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET66005000 Sculp. Wax SUPERPINK elastic, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6600500M0 Sculp. Wax SUPERPINK elastic, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET68000000SOLIDUS 80, base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6800000M0SOLIDUS 80, base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET68400000 SOLIDUS 84 base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6840000M0 SOLIDUS 84 base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
D800ZBAC6705WHI0Printer Resin Try-In & Burnout White (500g)ZIRKONZAHN SRLEGD2026-05-20
EYET60500600Bite regist. Metal foil wax, brownYeti Dentalprodukte GmbHEGD2026-05-11
EYET61001000Performed Bite rims, soft yellow “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6100100M0Performed Bite rims, soft yellow “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61101000 Performed Bite rims, hard, pink “strawb.”Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6110100M0 Performed Bite rims, hard, pink “strawb.”,Sample Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61204900Bite wax sticks, soft, yellow, “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6120490M0Bite wax sticks, soft, yellow, “lemon” ,SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61301000Performed Bite rims, medium “orange”, SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET6130100M0Performed Bite rims, medium “orange”, SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61304900Bite wax sticks, hard, pink, “strawb.” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6130490M0Bite wax sticks, hard, pink, “strawb.” , SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61401000Preformed Bite rims, very hard, pink Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6140100M0Preformed Bite rims, very hard, pink Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61404900 Bite wax sticks, medium, gree, “apple” Yeti Dentalprodukte GmbHEGD2026-05-11