What is FDA product code OFY?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Dental › ProstheticDental Implant Surgical Tray

Osteotome Kit

Name: Osteotome Kit
Brand: Osteotome Kit

Catalogue number HA1000, listed by Adin Dental Implant Systems Ltd., Israel, under Dental Implant Surgical Tray. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Hebei.

Chinese manufacturers registered for FDA product code OFY
Manufacturer	City	Province	Registered as	Device types
Cangzhou Lankang Medical Instruments Developing Co., Ltd.	Cangzhou	Hebei	Manufacturer	40
Huanghua DK Dental Co., Ltd.	Huanghua	Hebei	Manufacturer	37

Record

Regulatory record for Osteotome Kit
Listed by	Adin Dental Implant Systems Ltd., Israel
FDA product code	OFY
Device type	Dental Implant Surgical Tray
Device class	Class 1
Regulation	21 CFR 872.3980
Establishment	Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2017-04-23
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Osteotome Kit
Catalogue number	Size	Status
HA1000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Intra-Lock	Intra-Lock International	31
Ditron Dental	Ditron Dental Ltd	10
Restore	Keystone Dental Inc.	9
Prima	Keystone Dental Inc.	9
Stage-1	Keystone Dental Inc.	7
DIO Master Kit	DIO Corporation	6
Genesis	Keystone Dental Inc.	5
TRI	TRI Dental Implants INT. AG	5
FTN Surgical Kit	DIO Corporation	5
Stradis	Stradis Healthcare	5
UF(II) Starter Kit	DIO Corporation	4
RS-Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills	Adin Dental Implant Systems Ltd.	3

Showing 12 of 110. All products under Dental Implant Surgical Tray

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.