The following data is part of a premarket notification filed by Dental Disposables Intl., Inc. with the FDA for Allrap/slip-n-grip.
Device ID | K960352 |
510k Number | K960352 |
Device Name: | ALLRAP/SLIP-N-GRIP |
Classification | Handpiece, Air-powered, Dental |
Applicant | DENTAL DISPOSABLES INTL., INC. 15 SOUTH MAIN ST. Marlboro, NJ 07746 |
Contact | Jay Steinberg |
Correspondent | Jay Steinberg DENTAL DISPOSABLES INTL., INC. 15 SOUTH MAIN ST. Marlboro, NJ 07746 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-25 |
Decision Date | 1996-02-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00615375005118 | K960352 | 000 |
00615375004142 | K960352 | 000 |
00615375004159 | K960352 | 000 |
00615375004166 | K960352 | 000 |
00615375004173 | K960352 | 000 |
00615375004180 | K960352 | 000 |
00615375004197 | K960352 | 000 |
00615375004203 | K960352 | 000 |
00615375004210 | K960352 | 000 |
00615375004227 | K960352 | 000 |
00615375004234 | K960352 | 000 |
00615375004869 | K960352 | 000 |
00615375004968 | K960352 | 000 |
00615375004975 | K960352 | 000 |
00615375005095 | K960352 | 000 |
00615375004135 | K960352 | 000 |